{"id":1090,"date":"2026-07-06T06:11:39","date_gmt":"2026-07-06T06:11:39","guid":{"rendered":"https:\/\/isbm-blow-molding.com\/?p=1090"},"modified":"2026-07-06T06:11:39","modified_gmt":"2026-07-06T06:11:39","slug":"korean-kfda-gmp-pharmaceutical-ibm","status":"publish","type":"post","link":"https:\/\/isbm-blow-molding.com\/tr\/korean-kfda-gmp-pharmaceutical-ibm\/","title":{"rendered":"Kore KFDA IBM \u0130la\u00e7 Konteyneri GMP K\u0131lavuzu"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p><!-- \u2550\u2550 HERO \u2550\u2550 --><\/p>\n<header style=\"position: relative; min-height: min(600px,88vh); display: flex; align-items: flex-end; width: 100%; background: #06100e; background-image: linear-gradient(155deg,rgba(4,12,10,0.97) 0%,rgba(8,24,20,0.93) 52%,rgba(14,66,50,0.65) 100%),url('https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/07\/IBM-mold-3.webp'); background-size: cover; background-position: center 35%;\">\n<div style=\"position: absolute; top: 0; left: 0; right: 0; height: 5px; background: linear-gradient(90deg,#d97706,#f59e0b,#d97706);\"><\/div>\n<div style=\"position: absolute; bottom: -1px; left: 0; right: 0; height: 56px; background: #f0f3f7; clip-path: polygon(0 100%,100% 100%,100% 0);\"><\/div>\n<div style=\"position: relative; z-index: 2; width: 100%; padding: clamp(48px,7vw,96px) clamp(20px,5vw,60px) clamp(52px,6vw,84px); box-sizing: border-box;\">\n<div style=\"display: inline-flex; align-items: center; gap: 8px; margin-bottom: 20px;\">\n<div style=\"width: 28px; height: 3px; background: #d97706;\"><\/div>\n<p><span style=\"font-size: 10px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #f59e0b;\">D\u00dcZENLEME KILAVUZU \u00b7 KOREAN KFDA GMP \u00b7 IBM PHARMACEUTICAL \u00b7 KOREA EVER-POWER<\/span><\/p>\n<div style=\"width: 28px; height: 3px; background: #d97706;\"><\/div>\n<\/div>\n<h1 style=\"font-size: clamp(26px,4.6vw,46px); font-weight: 900; color: #fff; line-height: 1.1; margin: 0 0 20px; letter-spacing: -0.8px; max-width: 720px;\">Kore KFDA IBM<br \/>\n\u0130la\u00e7 Kab\u0131<br \/>\n<span style=\"color: #f59e0b;\">GMP K\u0131lavuzu<\/span><\/h1>\n<p style=\"font-size: clamp(14px,1.9vw,17px); color: #94a3b8; line-height: 1.7; margin: 0 0 30px; max-width: 600px;\">Kore'deki her IBM ila\u00e7 ambalaj projesinde, Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) ila\u00e7 kab\u0131 GMP yeterlilik belgesi, makine \u00fcretiminden, kal\u0131p \u00fcretiminden daha uzun s\u00fcren ve Korea Ever-Power'\u0131n teslimat h\u0131z\u0131ndan ba\u011f\u0131ms\u0131z olan kritik bir a\u015famad\u0131r. Bu k\u0131lavuz, HDPE ve PP IBM kaplar\u0131 i\u00e7in eksiksiz KFDA yeterlilik \u00e7er\u00e7evesini kapsamaktad\u0131r: dok\u00fcmantasyon gereksinimleri, Kore Farmakopesi test spesifikasyonlar\u0131, ekstraksiyon \u00e7al\u0131\u015fmalar\u0131 s\u00fcresi, kapak fonksiyonu yeterlilik belgesi ve bo\u015fluk say\u0131s\u0131 veya re\u00e7ine lotu de\u011fi\u015fti\u011finde de\u011fi\u015fiklik bildirim s\u00fcreci.<\/p>\n<div style=\"display: flex; flex-wrap: wrap; gap: 6px;\"><span style=\"background: rgba(217,119,6,0.15); border: 1px solid rgba(217,119,6,0.45); color: #fbbf24; font-size: 11px; font-weight: bold; padding: 4px 12px; border-radius: 2px; letter-spacing: 1px; text-transform: uppercase;\">Kore KP Testi Gereksinimleri<\/span><br \/>\n<span style=\"background: rgba(255,255,255,0.06); border: 1px solid rgba(255,255,255,0.15); color: #94a3b8; font-size: 11px; font-weight: bold; padding: 4px 12px; border-radius: 2px; letter-spacing: 1px; text-transform: uppercase;\">\u00c7\u0131kar\u0131labilir Maddeler \/ S\u0131zd\u0131r\u0131labilir Maddeler<\/span><br \/>\n<span style=\"background: rgba(255,255,255,0.06); border: 1px solid rgba(255,255,255,0.15); color: #94a3b8; font-size: 11px; font-weight: bold; padding: 4px 12px; border-radius: 2px; letter-spacing: 1px; text-transform: uppercase;\">KFDA De\u011fi\u015fiklik Bildirimi<\/span><\/div>\n<p style=\"font-size: 11px; color: #475569; margin: 22px 0 0; letter-spacing: 1px;\">KOREA EVER-POWER \u00b7 ANSAN-SI, GYEONGGI-DO \u00b7 TEMMUZ 2026<\/p>\n<\/div>\n<\/header>\n<p>&nbsp;<\/p>\n<p><!-- SPEC PANEL --><\/p>\n<div style=\"background: #0f1e35; border: 1px solid #1e3a5f; border-left: 4px solid #d97706; border-radius: 4px; padding: 24px 28px; margin: 52px 0 0;\">\n<div style=\"display: flex; align-items: center; gap: 10px; margin-bottom: 18px;\">\n<div style=\"width: 16px; height: 16px; border: 2px solid #d97706; border-radius: 50%; display: flex; align-items: center; justify-content: center; flex-shrink: 0;\">\n<div style=\"width: 6px; height: 6px; background: #d97706; border-radius: 50%;\"><\/div>\n<\/div>\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0;\">S\u0130STEM REFERANSI \u00b7 KOREAN KFDA IBM \u0130LA\u00c7 YETERL\u0130L\u0130K PARAMETRELER\u0130<\/p>\n<\/div>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(min(100%,170px),1fr)); gap: 1px; background: #1e3a5f;\">\n<div style=\"background: #0f1e35; padding: 16px 18px;\">\n<p style=\"font-size: 10px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #475569; margin: 0 0 6px;\">KR\u0130T\u0130K YOL S\u00dcRES\u0130<\/p>\n<p style=\"font-size: 26px; font-weight: 900; color: #f59e0b; margin: 0 0 4px; font-variant-numeric: tabular-nums;\">24 hafta<\/p>\n<p style=\"font-size: 12px; color: #64748b; margin: 0;\">\u0130lk IBM \u00fcretim \u00f6rne\u011finden yeterlilik dok\u00fcmantasyonunu tamamlamaya kadar ge\u00e7en minimum s\u00fcre<\/p>\n<\/div>\n<div style=\"background: #0f1e35; padding: 16px 18px;\">\n<p style=\"font-size: 10px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #475569; margin: 0 0 6px;\">KFDA DE\u011e\u0130\u015e\u0130KL\u0130K \u0130NCELEMES\u0130<\/p>\n<p style=\"font-size: 26px; font-weight: 900; color: #f59e0b; margin: 0 0 4px; font-variant-numeric: tabular-nums;\">3-6 ay<\/p>\n<p style=\"font-size: 12px; color: #64748b; margin: 0;\">\u00d6nemli de\u011fi\u015fiklik bildirimlerinin g\u00f6zden ge\u00e7irilme zaman \u00e7izelgesi \u2014 makine de\u011fi\u015fikli\u011fi, bo\u015fluk say\u0131s\u0131 de\u011fi\u015fikli\u011fi<\/p>\n<\/div>\n<div style=\"background: #0f1e35; padding: 16px 18px;\">\n<p style=\"font-size: 10px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #475569; margin: 0 0 6px;\">KP EXTRACABLES L\u0130M\u0130T<\/p>\n<p style=\"font-size: 26px; font-weight: 900; color: #f59e0b; margin: 0 0 4px; font-variant-numeric: tabular-nums;\">\u226430 ppm<\/p>\n<p style=\"font-size: 12px; color: #64748b; margin: 0;\">Buharla\u015fma kal\u0131nt\u0131 limiti \u2014 su, 4% asetik asit, n-heptan ekstraksiyon ortam\u0131<\/p>\n<\/div>\n<div style=\"background: #0f1e35; padding: 16px 18px;\">\n<p style=\"font-size: 10px; font-weight: bold; letter-spacing: 2px; text-transform: uppercase; color: #475569; margin: 0 0 6px;\">UYUMLULUK \u00c7ALI\u015eMASI<\/p>\n<p style=\"font-size: 26px; font-weight: 900; color: #f59e0b; margin: 0 0 4px; font-variant-numeric: tabular-nums;\">12 \/ 24 hafta<\/p>\n<p style=\"font-size: 12px; color: #64748b; margin: 0;\">A\u011f\u0131zdan uygulama: 12 hafta h\u0131zland\u0131r\u0131lm\u0131\u015f program \u00b7 Oftalmolojik uygulama: 24 hafta \u2014 en uzun kritik yol aktivitesi<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p><!-- TOC --><\/p>\n<nav style=\"margin: 28px 0 0; background: #fff; border: 1px solid #cbd5e0; border-radius: 4px; padding: 22px 26px; position: relative; overflow: hidden;\">\n<div style=\"position: absolute; inset: 0; background-image: linear-gradient(rgba(30,58,95,0.03) 1px,transparent 1px),linear-gradient(90deg,rgba(30,58,95,0.03) 1px,transparent 1px); background-size: 24px 24px; pointer-events: none;\"><\/div>\n<div style=\"position: relative;\">\n<div style=\"display: flex; align-items: center; gap: 8px; margin-bottom: 14px;\">\n<div style=\"width: 3px; height: 14px; background: #d97706; border-radius: 2px;\"><\/div>\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 2.5px; text-transform: uppercase; color: #1e3a5f; margin: 0;\">BELGE D\u0130Z\u0130N\u0130<\/p>\n<\/div>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(min(100%,270px),1fr)); gap: 2px 24px;\"><a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s1\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">01<\/span>Kore KFDA \u0130la\u00e7 Ambalaj \u00c7er\u00e7evesi<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s2\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">02<\/span>KFDA Kalifikasyonu i\u00e7in IBM Makine ve Bo\u015fluk Se\u00e7imi<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s3\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">03<\/span>Konteyner Teknik Dosyas\u0131 \u2014 Gerekli Belgeler<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s4\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">04<\/span>Kore Farmakopesi Plastik Kap Testleri<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s5\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">05<\/span>Uyumluluk ve Ekstraksiyon\/S\u0131z\u0131nt\u0131 \u00c7al\u0131\u015fmalar\u0131<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s6\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">06<\/span>Kapanma Fonksiyonu ve Boyutsal Yeterlilik<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s7\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">07<\/span>Kore KFDA De\u011fi\u015fiklik Bildirim S\u00fcreci<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline; border-bottom: 1px solid #f1f5f9;\" href=\"#s8\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">08<\/span>Korea Ever-Power GMP Dok\u00fcmantasyon Deste\u011fi<\/a><br \/>\n<a style=\"color: #1e3a5f; text-decoration: none; font-size: 13.5px; padding: 4px 0; display: flex; align-items: baseline;\" href=\"#faq\"><span style=\"color: #d97706; font-size: 10px; font-weight: 800; margin-right: 8px; flex-shrink: 0;\">SSS<\/span>D\u00fczenleyici M\u00fchendislik Sorular\u0131<\/a><\/div>\n<\/div>\n<\/nav>\n<p><!-- \u2550\u2550 S1 \u2550\u2550 --><\/p>\n<div style=\"padding: 0px 2%;\">\n<section id=\"s1\" style=\"margin: 64px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 01<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Kore KFDA \u0130la\u00e7 Ambalaj\u0131 D\u00fczenleme \u00c7er\u00e7evesi<\/h2>\n<\/div>\n<\/div>\n<figure style=\"margin: 0 0 24px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 3px; display: block; border: 1px solid #cbd5e0;\" title=\"Kore KFDA \u0130la\u00e7 IBM Konteyner GMP Kalifikasyonu\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/07\/Pharmaceutical-Bottles.webp\" alt=\"Kore KFDA ila\u00e7 IBM konteyner yeterlilik belgesi gerektiren HDPE oftalmik oral s\u0131v\u0131 CRC ila\u00e7 konteynerleri Kore Farmakopesi KP plastik konteyner testi s\u0131zd\u0131r\u0131labilir maddeler uyumluluk \u00e7al\u0131\u015fmas\u0131\" \/><figcaption style=\"font-size: 12px; color: #64748b; margin-top: 8px; padding-left: 10px; border-left: 2px solid #d97706;\">Kore ila\u00e7 end\u00fcstrisinin IBM taraf\u0131ndan kullan\u0131lan birincil ambalajlar\u0131 (HDPE oftalmik, oral s\u0131v\u0131 ve CRC ila\u00e7 formatlar\u0131) her biri, Kore KFDA ila\u00e7 ambalaj\u0131 yeterlilik testini gerektirir; bu testler Kore KP plastik ambalaj testlerini, kimyasal uyumlulu\u011fu, kapak fonksiyon testlerini ve t\u00fcm \u00fcretim bo\u015fluklar\u0131nda boyut dok\u00fcmantasyonunu i\u00e7erir.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore'de ila\u00e7 ambalajlar\u0131n\u0131n birincil kaplar\u0131n\u0131n yeterlilik de\u011ferlendirmesi, Kore \u0130la\u00e7 \u0130\u015fleri Kanunu (\uc57d\uc0ac\ubc95, 18651 say\u0131l\u0131 Kanun), G\u0131da ve \u0130la\u00e7 G\u00fcvenli\u011fi Bakanl\u0131\u011f\u0131 (MFDS\/KFDA, \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98) taraf\u0131ndan yay\u0131mlanan Kore \u0130yi \u00dcretim Uygulamalar\u0131 (GMP) y\u00f6netmelikleri ve ila\u00e7 kullan\u0131m\u0131na y\u00f6nelik plastik kaplar i\u00e7in monograf\u0131 i\u00e7eren Kore Farmakopesi (KP, \ub300\ud55c\uc57d\uc804) taraf\u0131ndan d\u00fczenlenmektedir. Bu \u00fc\u00e7 d\u00fczenleyici ara\u00e7 farkl\u0131 seviyelerde i\u015flev g\u00f6rmektedir: \u0130la\u00e7 \u0130\u015fleri Kanunu, birincil kaplar\u0131n yeterlilik de\u011ferlendirmesini zorunlu k\u0131lar; GMP y\u00f6netmeli\u011fi, kap yeterlilik de\u011ferlendirmesinin yap\u0131lmas\u0131 ve belgelendirilmesi gereken kalite sistemini tan\u0131mlar; ve KP plastik kap monograf\u0131, HDPE veya PP IBM kab\u0131n\u0131n ge\u00e7mesi gereken kimyasal testleri ve limitleri belirtir.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">IBM konteynerleri, Kore ila\u00e7 sekt\u00f6r\u00fcnde birincil ambalaj olarak kullan\u0131l\u0131r; bu da ila\u00e7 \u00fcr\u00fcn\u00fcyle do\u011frudan temas eden ambalaj malzemesi olarak tan\u0131mlan\u0131r. Bu s\u0131n\u0131fland\u0131rma, yaln\u0131zca genel Kore ambalaj malzemesi standartlar\u0131na tabi olan ikincil ambalajlardan (d\u0131\u015f kartonlar, sevkiyat kutular\u0131) ay\u0131r\u0131r; ikincil ambalajlar ise tam KP ila\u00e7 konteyneri yeterlilik gereksinimine tabi de\u011fildir. Her Kore ila\u00e7 \u00fcr\u00fcn\u00fcn\u00fcn birincil konteyneri, malzeme t\u00fcr\u00fc, tedarik\u00e7i kimli\u011fi ve boyut \u00f6zellikleri ile Kore KFDA'ya kay\u0131tl\u0131 \u00fcr\u00fcn dosyas\u0131nda listelenir. \u0130lk KFDA kayd\u0131ndan sonra birincil konteynerde yap\u0131lacak herhangi bir de\u011fi\u015fiklik, resmi bir de\u011fi\u015fiklik bildirimi gerektirir; bu, onay sonras\u0131 de\u011fi\u015fiklik bildiriminin Kore'deki kar\u015f\u0131l\u0131\u011f\u0131d\u0131r ve inceleme zaman \u00e7izelgesi (k\u00fc\u00e7\u00fck de\u011fi\u015fiklikler i\u00e7in kendi beyan\u0131, b\u00fcy\u00fck de\u011fi\u015fiklikler i\u00e7in 3-6 ay), Kore ila\u00e7 ambalaj geli\u015ftirme ve tedarik zinciri y\u00f6netiminde s\u0131kl\u0131kla kritik bir unsurdur.<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">Kore ila\u00e7 ambalaj\u0131nda \u200b\u200bIBM'in daha kapsaml\u0131 ba\u011flam\u0131 \u2014 konteyner formatlar\u0131, HDPE ve PP malzeme \u00f6zellikleri, temiz oda \u00fcretim gereksinimleri ve makine se\u00e7imi \u2014 ila\u00e7 sekt\u00f6r\u00fcne y\u00f6nelik IBM k\u0131lavuzunda ele al\u0131nmaktad\u0131r. Bu k\u0131lavuz, \u00f6zellikle Koreli IBM konteyner \u00fcreticilerinin makine sipari\u015finden ticari \u00fcretim onay\u0131na kadar izlemesi gereken Kore KFDA GMP yeterlilik yoluna odaklanmaktad\u0131r.<\/p>\n<\/section>\n<p><!-- \u2550\u2550 S2 \u2550\u2550 --><\/p>\n<section id=\"s2\" style=\"margin: 56px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 02<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Kore KFDA Kalifikasyonu i\u00e7in IBM Makine ve Kal\u0131p Se\u00e7imi<\/h2>\n<\/div>\n<\/div>\n<figure style=\"margin: 0 0 24px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 3px; display: block; border: 1px solid #cbd5e0;\" title=\"ZQ Serisi IBM Makinesi \u2014 Kore KFDA \u0130la\u00e7 Onayl\u0131\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/07\/IBM-Internal-structure.webp\" alt=\"Kore Ever-Power ZQ serisi IBM makinesinin i\u00e7 yap\u0131s\u0131 \u2014 Kore KFDA ila\u00e7 konteyneri yeterlilik dok\u00fcmantasyonu i\u00e7in makine seri numaras\u0131 tan\u0131mlamas\u0131, \u00e7ift hidrolik sistem, ila\u00e7 HDPE \u00fcretimi i\u00e7in 4+N varil b\u00f6lgesi konfig\u00fcrasyonu.\" \/><figcaption style=\"font-size: 12px; color: #64748b; margin-top: 8px; padding-left: 10px; border-left: 2px solid #d97706;\">Korea Ever-Power ZQ serisi makineler \u2014 her makine, Kore KFDA ila\u00e7 kab\u0131 yeterlilik teknik dosyas\u0131nda kay\u0131tl\u0131 benzersiz bir seri numaras\u0131na sahiptir. Makine seri numaras\u0131, belirli kal\u0131p seti numaras\u0131 ve bo\u015fluk say\u0131s\u0131 ile birlikte, yeterlili\u011fi tam \u00fcretim konfig\u00fcrasyonuna ba\u011flayan \u00fcretim ekipman\u0131 tan\u0131mlay\u0131c\u0131s\u0131n\u0131 olu\u015fturur. Bu konfig\u00fcrasyonda yap\u0131lacak herhangi bir sonraki de\u011fi\u015fiklik, Kore KFDA'ya de\u011fi\u015fiklik bildirimi yap\u0131lmas\u0131n\u0131 gerektirir.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 20px;\"><a href=\"https:\/\/isbm-blow-molding.com\/tr\/product-category\/injection-blow-molding-machine\/\">IBM makinesi<\/a> Kore ila\u00e7 \u00fcretiminde kullan\u0131lan kal\u0131p se\u00e7imi, ev kimyasallar\u0131 veya kozmetik \u00fcr\u00fcnlerinde kullan\u0131lmayan benzersiz bir d\u00fczenleyici k\u0131s\u0131tlamay\u0131 beraberinde getirir: Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) ila\u00e7 kab\u0131 yeterlilik belgesi, \u00fcretim makinesini seri numaras\u0131yla ve kal\u0131p setini bo\u015fluk say\u0131s\u0131yla a\u00e7\u0131k\u00e7a tan\u0131mlar. Bu, makine sipari\u015finde se\u00e7ilen ZQ modelinin sadece bir \u00fcretim kapasitesi karar\u0131 olmad\u0131\u011f\u0131 anlam\u0131na gelir; \u00fcr\u00fcn\u00fcn ticari \u00f6mr\u00fc boyunca yeterlilik zaman \u00e7izelgesini ve de\u011fi\u015fiklik bildirim y\u00fck\u00fcn\u00fc belirleyen bir d\u00fczenleyici taahh\u00fctt\u00fcr.<\/p>\n<p><!-- KFDA lock-in matrix --><\/p>\n<div style=\"background: #0f1e35; border-radius: 4px; padding: 22px 26px; margin: 0 0 22px; border-top: 3px solid #d97706;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 16px;\">MEVZUAT K\u0130L\u0130TLEME MATR\u0130S\u0130 \u00b7 ZQ MODEL\u0130 \u00d7 KFDA YETERL\u0130L\u0130K ETK\u0130S\u0130<\/p>\n<div style=\"overflow-x: auto;\">\n<table style=\"width: 100%; border-collapse: collapse; font-size: 13px; min-width: 580px;\">\n<thead>\n<tr style=\"background: #1e3a5f;\">\n<th style=\"color: #f59e0b; padding: 10px 12px; text-align: left; font-weight: bold; border-right: 1px solid #0f1e35;\">SENARYO<\/th>\n<th style=\"color: #e2e8f0; padding: 10px 10px; text-align: center; font-weight: bold; border-right: 1px solid #0f1e35;\">KFDA EYLEM\u0130<\/th>\n<th style=\"color: #e2e8f0; padding: 10px 10px; text-align: center; font-weight: bold; border-right: 1px solid #0f1e35;\">\u0130NCELEME ZAMAN \u00c7\u0130ZELGES\u0130<\/th>\n<th style=\"color: #e2e8f0; padding: 10px 10px; text-align: left; font-weight: bold;\">PLANLAMA A\u00c7ISINDAN SONU\u00c7LARI<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr style=\"background: #0f1e35;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; font-weight: 600; color: #e2e8f0;\">\u0130lk yeterlilik testi \u2014 ZQ80, 20 kavite, 10 ml<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #34d399; font-weight: bold;\">Konteyner Teknik Dosyas\u0131 G\u00f6nderimi<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #34d399;\">KFDA incelemesi i\u00e7in bekleme yok.<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; color: #94a3b8; font-size: 12px;\">Koreli bir ila\u00e7 markas\u0131, ticari kullan\u0131ma ge\u00e7meden \u00f6nce dahili CTF testini do\u011frulad\u0131.<\/td>\n<\/tr>\n<tr style=\"background: #122338;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; font-weight: 600; color: #e2e8f0;\">Re\u00e7ine parti de\u011fi\u015fikli\u011fi \u2014 ayn\u0131 kalite, ayn\u0131 tedarik\u00e7i<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #fbbf24; font-weight: bold;\">K\u00fc\u00e7\u00fck de\u011fi\u015fiklik \u00f6z beyan\u0131<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #fbbf24;\">Hemen<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; color: #94a3b8; font-size: 12px;\">CoA dok\u00fcmantasyonunu muhafaza edin; MI ve yo\u011funlu\u011fun nitelikli aral\u0131kta oldu\u011funu do\u011frulay\u0131n.<\/td>\n<\/tr>\n<tr style=\"background: #0f1e35;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; font-weight: 600; color: #e2e8f0;\">Ayn\u0131 ZQ modeli, bo\u015fluk say\u0131s\u0131 de\u011fi\u015fimi (20\u219224)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #f87171; font-weight: bold;\">\u00d6nemli de\u011fi\u015fiklik bildirimi<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #f87171;\">3-6 ay<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; color: #94a3b8; font-size: 12px;\">Her bo\u015fluk i\u00e7in ayr\u0131 ayr\u0131 yeni boyutland\u0131rma raporu gereklidir; duvarda de\u011fi\u015fiklik olmas\u0131 durumunda tam KP yeniden testi yap\u0131lmal\u0131d\u0131r.<\/td>\n<\/tr>\n<tr style=\"background: #122338;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; font-weight: 600; color: #e2e8f0;\">ZQ model y\u00fckseltmesi (ZQ80\u2192ZQ110)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #f87171; font-weight: bold;\">\u00d6nemli de\u011fi\u015fiklik bildirimi<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #f87171;\">3-6 ay<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; color: #94a3b8; font-size: 12px;\">CTF'de yeni makine seri numaras\u0131; yeni bo\u015fluk say\u0131s\u0131nda tam boyutsal yeterlilik testi tekrar\u0131.<\/td>\n<\/tr>\n<tr style=\"background: #0f1e35;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; font-weight: 600; color: #e2e8f0;\">Re\u00e7ine s\u0131n\u0131f\u0131 de\u011fi\u015fimi (ayn\u0131 polimer s\u0131n\u0131f\u0131)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #f87171; font-weight: bold;\">\u00d6nemli de\u011fi\u015fiklik bildirimi<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; border-right: 1px solid #1e3a5f; text-align: center; color: #f87171;\">3-6 ay<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #1e3a5f; color: #94a3b8; font-size: 12px;\">Yeni KP \u00f6z\u00fctlenebilir madde testleri; yeni kalite ile uyumluluk \u00e7al\u0131\u015fmas\u0131.<\/td>\n<\/tr>\n<tr style=\"background: #122338;\">\n<td style=\"padding: 9px 12px; border-right: 1px solid #1e3a5f; font-weight: 600; color: #f59e0b;\">\u00d6n onayl\u0131 \u00e7ift makine (ZQ80 + ZQ110)<\/td>\n<td style=\"padding: 9px 10px; border-right: 1px solid #1e3a5f; text-align: center; color: #34d399; font-weight: bold;\">Her ikisi de ilk CTF'de \u00f6nceden onaylanm\u0131\u015ft\u0131r.<\/td>\n<td style=\"padding: 9px 10px; border-right: 1px solid #1e3a5f; text-align: center; color: #34d399;\">Ekstra bekleme s\u00fcresi yok.<\/td>\n<td style=\"padding: 9px 10px; color: #94a3b8; font-size: 12px;\">En iyi uygulama stratejisi: \u0130lk CTF'de her iki makineyi de test edin \u2014 bu, \u00f6l\u00e7eklendirme s\u0131ras\u0131nda ilerideki 3-6 ayl\u0131k bekleme s\u00fcresini ortadan kald\u0131r\u0131r.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 0;\">Stratejik \u00e7\u0131kar\u0131m a\u00e7\u0131k: \u00d6l\u00e7ek b\u00fcy\u00fctmeyi \u00f6ng\u00f6ren Koreli ila\u00e7 IBM \u00fcreticileri, \u00f6l\u00e7ek b\u00fcy\u00fctme ger\u00e7ekle\u015fti\u011finde 3-6 ayl\u0131k KFDA inceleme s\u00fcresini ortadan kald\u0131rmak i\u00e7in, ilk makineyi ve beklenen bir sonraki model makineyi ayn\u0131 anda, m\u00fctevaz\u0131 bir ek dok\u00fcmantasyon maliyetiyle, ilk konteyner teknik dosyas\u0131nda onaylamal\u0131d\u0131r. Kore Ever-Power <a style=\"color: #1e3a5f; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/tr\/product\/ep-zq80-injection-blow-molding-machine-european-style\/\">EP-ZQ80 IBM makinesi<\/a> ZQ80 ve EP-ZQ110, Kore ila\u00e7 sekt\u00f6r\u00fcndeki IBM projelerinde en s\u0131k \u00f6n yeterlilik alan makine \u00e7iftidir; ZQ80 birincil \u00fcretim makinesi, ZQ110 ise onayl\u0131 ikincil makine olarak g\u00f6rev yapar ve her iki seri numaras\u0131 da ilk CTF'de kay\u0131tl\u0131d\u0131r.<\/p>\n<\/section>\n<p><!-- \u2550\u2550 S3 \u2550\u2550 --><\/p>\n<section id=\"s3\" style=\"margin: 56px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 03<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Konteyner Teknik Dosyas\u0131 \u2014 Gerekli Belgeler<\/h2>\n<\/div>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">Konteyner Teknik Dosyas\u0131 (CTF), Koreli bir ila\u00e7 markas\u0131n\u0131n kalite g\u00fcvence ekibinin, konteynerin ticari \u00fcretimde kullan\u0131m i\u00e7in onaylanabilmesi \u00f6ncesinde IBM konteyner tedarik\u00e7isinden talep etti\u011fi birincil dok\u00fcmantasyon sunumudur. Korea Ever-Power, her ila\u00e7 IBM makinesi ve kal\u0131p seti sipari\u015fiyle birlikte a\u015fa\u011f\u0131daki dok\u00fcmantasyon bile\u015fenlerini standart teslimat kalemleri olarak sa\u011flar; bu da veri toplama a\u015famas\u0131n\u0131 ortadan kald\u0131rarak Koreli ila\u00e7 markas\u0131n\u0131n yeterlilik s\u00fcrecini k\u0131salt\u0131r.<\/p>\n<p><!-- Document checklist - engineering style --><\/p>\n<div style=\"display: flex; flex-direction: column; gap: 2px; margin: 0 0 22px;\">\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-radius: 4px 4px 0 0; overflow: hidden;\">\n<div style=\"background: #1e3a5f; padding: 10px 16px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">DOC 01<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff; letter-spacing: 0.5px;\">RE\u00c7\u0130NE \u00d6ZELL\u0130KLER\u0130 VE UYUMLULUK BEYANI<\/span><br \/>\n<span style=\"margin-left: auto; background: rgba(52,211,153,0.2); color: #34d399; font-size: 10px; font-weight: bold; padding: 2px 8px; border-radius: 2px;\">KOREA EVER-POWER SA\u011eLAR<\/span><\/div>\n<div style=\"padding: 14px 18px;\">\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 6px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Re\u00e7ine \u00fcreticisinin ad\u0131, HDPE veya PP ticari s\u0131n\u0131f tan\u0131m\u0131, parti numaras\u0131<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Analiz Sertifikas\u0131: MI (g\/10dk), yo\u011funluk (g\/cm\u00b3), erime noktas\u0131, katk\u0131 maddesi paket bile\u015fimi<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Re\u00e7ine tedarik\u00e7isinden Kore KFDA pozitif liste referans\u0131 veya KFDA ila\u00e7 temas beyan\u0131.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Onay: UV stabilizat\u00f6r\u00fc i\u00e7ermez, listede olmayan kayganla\u015ft\u0131r\u0131c\u0131 madde i\u00e7ermez, yasakl\u0131 renklendirici i\u00e7ermez.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; overflow: hidden;\">\n<div style=\"background: #1e3a5f; padding: 10px 16px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">DOC 02<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff; letter-spacing: 0.5px;\">KONTEYNER BOYUT \u00c7\u0130Z\u0130M\u0130<\/span><br \/>\n<span style=\"margin-left: auto; background: rgba(52,211,153,0.2); color: #34d399; font-size: 10px; font-weight: bold; padding: 2px 8px; border-radius: 2px;\">KOREA EVER-POWER SA\u011eLAR<\/span><\/div>\n<div style=\"padding: 14px 18px;\">\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 6px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Toleranslar\u0131yla birlikte t\u00fcm nominal boyutlar: boyun d\u0131\u015f \u00e7ap\u0131, boyun i\u00e7 \u00e7ap\u0131, y\u00fckseklik, g\u00f6vde maksimum d\u0131\u015f \u00e7ap\u0131, dolum i\u015fareti konumu.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Dolum \u00e7izgisindeki hacim: 23\u00b0C'de nominal hacim \u00b1 tolerans<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Konteyner malzemesi tan\u0131mlamas\u0131: HDPE veya PP, renk, re\u00e7ine tan\u0131mlama kodu.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Kore KFDA dosyas\u0131ndaki s\u00fcr\u00fcm kontrol\u00fc i\u00e7in revizyon ge\u00e7mi\u015fi ve \u00e7izim numaras\u0131.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; overflow: hidden;\">\n<div style=\"background: #1e3a5f; padding: 10px 16px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">DOC 03<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff; letter-spacing: 0.5px;\">MAK\u0130NE VE KALIP TANIMLAMASI<\/span><br \/>\n<span style=\"margin-left: auto; background: rgba(52,211,153,0.2); color: #34d399; font-size: 10px; font-weight: bold; padding: 2px 8px; border-radius: 2px;\">KOREA EVER-POWER SA\u011eLAR<\/span><\/div>\n<div style=\"padding: 14px 18px;\">\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 6px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Kore Ever-Power makine modeli (\u00f6rne\u011fin EP-ZQ80) ve benzersiz makine seri numaras\u0131<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Kal\u0131p seti seri numaras\u0131, bo\u015fluk say\u0131s\u0131, kal\u0131p malzemesi (S136 paslanmaz \u00e7elik), bo\u015fluk numaraland\u0131rma d\u00fczeni \u015femas\u0131<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>\u00dcretim tesisinin ad\u0131 ve adresi (Koreli IBM konteyner \u00fcreticisinin tesisi)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>\u00c7ift makine yeterlili\u011fi s\u00f6z konusuysa: hem seri numaralar\u0131 hem de bo\u015fluk say\u0131lar\u0131 belgelenmelidir.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; overflow: hidden;\">\n<div style=\"background: #1e3a5f; padding: 10px 16px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">DOC 04<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff; letter-spacing: 0.5px;\">BO\u015eLUK BAZINDA BOYUTSAL N\u0130TEL\u0130K RAPORU<\/span><br \/>\n<span style=\"margin-left: auto; background: rgba(52,211,153,0.2); color: #34d399; font-size: 10px; font-weight: bold; padding: 2px 8px; border-radius: 2px;\">KOREA EVER-POWER SA\u011eLAR<\/span><\/div>\n<div style=\"padding: 14px 18px;\">\n<p style=\"font-size: 14px; color: #374151; margin: 0 0 10px; line-height: 1.65;\">Korea Ever-Power, bu raporu makine sevkiyat\u0131ndan \u00f6nce Korea Ever-Power tesisinde yap\u0131lan \u00f6n teslimat \u00fcretim denemesi s\u0131ras\u0131nda haz\u0131rlayarak, Koreli ila\u00e7 markas\u0131na makine Kore fabrikas\u0131na ula\u015fmadan \u00f6nce ilk parti boyut verilerini sa\u011fl\u0131yor. Bu \u00f6n teslimat raporu, ilk \u00fcretim \u00e7al\u0131\u015fmas\u0131ndan elde edilen do\u011frulanm\u0131\u015f boyut verilerini sa\u011flayarak Koreli m\u00fc\u015fterinin yerinde kalifikasyon s\u00fcresini k\u0131saltan benzersiz bir Korea Ever-Power hizmetidir.<\/p>\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 6px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Her bir bo\u015fluk i\u00e7in boyut ba\u015f\u0131na 30 \u00f6l\u00e7\u00fcm (boyun d\u0131\u015f \u00e7ap\u0131, i\u00e7 \u00e7ap, y\u00fckseklik, hacim, \u015fi\u015fe a\u011f\u0131rl\u0131\u011f\u0131)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>T\u00fcm bo\u015fluklar, 3 ard\u0131\u015f\u0131k \u00fcretim d\u00f6ng\u00fcs\u00fc boyunca \u00f6l\u00e7\u00fclm\u00fc\u015ft\u00fcr (minimum 500 \u015fi\u015fe).<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>\u0130statistiksel \u00f6zet: her boyut ve her bo\u015fluk i\u00e7in ortalama, aral\u0131k, standart sapma; Cpk \u2265 1,33 onay\u0131<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Kore KFDA CTF i\u00e7in gerekli olan, t\u00fcm bo\u015fluklar\u0131n ayn\u0131 anda belirtilen s\u0131n\u0131rlar i\u00e7inde oldu\u011funu do\u011frulayan beyan.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-radius: 0 0 4px 4px; overflow: hidden;\">\n<div style=\"background: #1e3a5f; padding: 10px 16px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #475569; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">DOC 05\u201307<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff; letter-spacing: 0.5px;\">KP TESTLER\u0130 \u00b7 UYUMLULUK \u00b7 KAPATMA FONKS\u0130YONU (Koreli m\u00fc\u015fteri taraf\u0131ndan sa\u011flanm\u0131\u015ft\u0131r)<\/span><br \/>\n<span style=\"margin-left: auto; background: rgba(100,116,139,0.25); color: #94a3b8; font-size: 10px; font-weight: bold; padding: 2px 8px; border-radius: 2px;\">M\u00dc\u015eTER\u0130 AYARLAR<\/span><\/div>\n<div style=\"padding: 14px 18px;\">\n<p style=\"font-size: 14px; color: #374151; margin: 0; line-height: 1.65;\">Kore Farmakopesi plastik kap test sertifikas\u0131 (Kore akredite laboratuvar\u0131), kimyasal uyumluluk \u00e7al\u0131\u015fmas\u0131 (ger\u00e7ek ila\u00e7 form\u00fclasyonu kullan\u0131larak 40\u00b0C\/75% RH'de 12 veya 24 hafta) ve kapak fonksiyon testi (KS M ISO 8317'ye g\u00f6re CRC, ASTM F2096'ya g\u00f6re ind\u00fcksiyon contas\u0131 veya damlal\u0131k kapa\u011f\u0131 yerle\u015ftirme torku). Bu \u00fc\u00e7 belge, Kore ila\u00e7 markas\u0131 veya IBM kap tedarik\u00e7isi taraf\u0131ndan temin edilir, \u00e7\u00fcnk\u00fc bunlar belirli ila\u00e7 form\u00fclasyonuna ve belirli Kore kapak bile\u015fenlerine eri\u015fim gerektirir. Her testin ayr\u0131nt\u0131l\u0131 \u00f6zellikleri bu k\u0131lavuzun 4, 5 ve 6. b\u00f6l\u00fcmlerinde ele al\u0131nm\u0131\u015ft\u0131r.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p><!-- \u2550\u2550 S4 \u2550\u2550 --><\/p>\n<section id=\"s4\" style=\"margin: 56px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 04<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Kore Farmakopesi Plastik Kap Testleri<\/h2>\n<\/div>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">Kore Farmakopesi (KP) \u0130la\u00e7 Kullan\u0131m\u0131na Y\u00f6nelik Plastik Kaplar Genel Monograf\u0131, HDPE ve PP ila\u00e7 kaplar\u0131 i\u00e7in alt\u0131 kimyasal test parametresi belirtmektedir. T\u00fcm testler, \u00fcretim kaplar\u0131 kullan\u0131larak yap\u0131lmal\u0131d\u0131r; ana kar\u0131\u015f\u0131m plakalar\u0131 veya enjeksiyon kal\u0131plama y\u00f6ntemiyle \u00fcretilmi\u015f test par\u00e7alar\u0131 kullan\u0131lmamal\u0131d\u0131r, \u00e7\u00fcnk\u00fc IBM proses ko\u015fullar\u0131 (varil s\u0131cakl\u0131\u011f\u0131, enjeksiyon bas\u0131nc\u0131, kab\u0131n i\u00e7 k\u0131sm\u0131ndaki \u00fcfleme havas\u0131na maruz kalma) bitmi\u015f kab\u0131n ekstraksiyon profilini etkiler.<\/p>\n<div style=\"overflow-x: auto; margin: 0 0 22px;\">\n<table style=\"width: 100%; border-collapse: collapse; font-size: 13px; min-width: 580px;\">\n<thead>\n<tr style=\"background: #0f1e35;\">\n<th style=\"color: #f59e0b; padding: 11px 12px; text-align: left; font-weight: bold; border-right: 1px solid #1e3a5f;\">KP TEST PARAMETRES\u0130<\/th>\n<th style=\"color: #e2e8f0; padding: 11px 10px; text-align: left; font-weight: bold; border-right: 1px solid #1e3a5f;\">EKSTRAKS\u0130YON KO\u015eULU<\/th>\n<th style=\"color: #f59e0b; padding: 11px 10px; text-align: center; font-weight: bold; border-right: 1px solid #1e3a5f;\">KP SINIRI<\/th>\n<th style=\"color: #e2e8f0; padding: 11px 10px; text-align: left; font-weight: bold;\">IBM R\u0130SK FAKT\u00d6R\u00dc<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr style=\"background: #fff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Buharla\u015fma kal\u0131nt\u0131s\u0131 (su)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0;\">Ar\u0131t\u0131lm\u0131\u015f su, 121\u00b0C, 1 saat<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; font-weight: bold; color: #059669;\">\u2264 30 ppm<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">Namlu a\u015f\u0131r\u0131 \u0131s\u0131nmas\u0131 nedeniyle y\u00fckselir (&gt;220\u00b0C nozulda); namlu b\u00f6lgesi ayar noktalar\u0131n\u0131 izleyin.<\/td>\n<\/tr>\n<tr style=\"background: #f8fafc;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Buharla\u015fma kal\u0131nt\u0131s\u0131 (4% asetik asit)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0;\">4% CH\u2083COOH, 60\u00b0C, 30 dk<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; font-weight: bold; color: #059669;\">\u2264 30 ppm<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">Antioksidan g\u00f6\u00e7\u00fcne kar\u015f\u0131 hassast\u0131r; yaln\u0131zca KFDA onayl\u0131 AO-1010 veya AO-168 s\u0131n\u0131f\u0131 oldu\u011fundan emin olun.<\/td>\n<\/tr>\n<tr style=\"background: #fff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Buharla\u015fma kal\u0131nt\u0131s\u0131 (n-heptan)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0;\">n-Heptan, 25\u00b0C, 1 saat<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; font-weight: bold; color: #059669;\">\u2264 30 ppm<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">HDPE IBM i\u00e7in risk d\u00fc\u015f\u00fck; kal\u0131p ay\u0131r\u0131c\u0131 madde kullan\u0131lmas\u0131 durumunda risk artar \u2014 IBM kal\u0131p ay\u0131r\u0131c\u0131 madde kullanmaz.<\/td>\n<\/tr>\n<tr style=\"background: #f8fafc;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">A\u011f\u0131r metaller (\u00f6rne\u011fin kur\u015fun)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0;\">4% CH\u2083COOH \u00f6z\u00fct\u00fc<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; font-weight: bold; color: #059669;\">\u2264 1 ppm<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">HDPE\/PP i\u00e7in risk d\u00fc\u015f\u00fck; \u0131s\u0131 stabilizat\u00f6rleri riski art\u0131r\u0131yor \u2014 farmas\u00f6tik IBM kalitelerinde \u0131s\u0131 stabilizat\u00f6r\u00fc bulunmuyor.<\/td>\n<\/tr>\n<tr style=\"background: #fff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Fenol<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0;\">Kloroform\/EtOH \u00f6z\u00fct\u00fc<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; font-weight: bold; color: #059669;\">\u2264 5 ppm<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">Fenolik antioksidanlar (AO-1010, BHT) \u2014 farmas\u00f6tik HDPE'de toplam AO y\u00fck\u00fcn\u00fc \u2264 0,05% seviyesinde tutar.<\/td>\n<\/tr>\n<tr style=\"background: #f8fafc;\">\n<td style=\"padding: 9px 12px; border-right: 1px solid #e2e8f0; font-weight: 600;\">KMnO\u2084 t\u00fcketimi<\/td>\n<td style=\"padding: 9px 10px; border-right: 1px solid #e2e8f0;\">Ar\u0131t\u0131lm\u0131\u015f su \u00f6z\u00fct\u00fc<\/td>\n<td style=\"padding: 9px 10px; border-right: 1px solid #e2e8f0; text-align: center; font-weight: bold; color: #059669;\">\u2264 10 ppm<\/td>\n<td style=\"padding: 9px 10px; font-size: 12px; color: #475569;\">Is\u0131l bozunma \u00fcr\u00fcnleri nedeniyle y\u00fckselmi\u015f \u2014 IBM silindirinin a\u015f\u0131r\u0131 \u0131s\u0131nd\u0131\u011f\u0131n\u0131n g\u00f6stergesi; do\u011fru ayar noktalar\u0131nda \u00e7al\u0131\u015ft\u0131r\u0131n.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-left: 4px solid #d97706; padding: 14px 20px; border-radius: 0 4px 4px 0;\">\n<p style=\"font-size: 13.5px; color: #374151; margin: 0; line-height: 1.7;\"><strong style=\"color: #0f1e35;\">Test laboratuvar\u0131 gereksinimi:<\/strong> Kore KFDA ila\u00e7 yeterlilik onay\u0131 i\u00e7in KP plastik kap testleri, Kore KFDA taraf\u0131ndan akredite edilmi\u015f bir ila\u00e7 test laboratuvar\u0131nda (\ud55c\uad6d\uc758\uc57d\ud488\uc2dc\ud5d8\uc6d0, KFDA'ya kay\u0131tl\u0131 s\u00f6zle\u015fmeli laboratuvar veya Kore GMP akreditasyonuna sahip kurum i\u00e7i laboratuvar) yap\u0131lmal\u0131d\u0131r. Akredite edilmemi\u015f laboratuvarlardan al\u0131nan sonu\u00e7lar, Kore KFDA ila\u00e7 kab\u0131 de\u011fi\u015fiklik bildirimlerinde kabul edilmez. Kore akredite laboratuvarlar\u0131nda test s\u00fcresi: numune g\u00f6nderiminden nihai test raporuna kadar genellikle 3-5 hafta. Genel yeterlilik zaman \u00e7izelgesine eklenen ard\u0131\u015f\u0131k gecikmeleri \u00f6nlemek i\u00e7in bunu uyumluluk testleriyle (B\u00f6l\u00fcm 5) paralel olarak planlay\u0131n.<\/p>\n<\/div>\n<\/section>\n<p><!-- \u2550\u2550 S5 \u2550\u2550 --><\/p>\n<section id=\"s5\" style=\"margin: 56px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 05<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Uyumluluk ve Ekstraksiyon\/S\u0131z\u0131nt\u0131 \u00c7al\u0131\u015fmalar\u0131<\/h2>\n<\/div>\n<\/div>\n<figure style=\"margin: 0 0 24px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 3px; display: block; border: 1px solid #cbd5e0;\" title=\"IBM \u0130la\u00e7 Konteyner \u00dcretimi \u2014 Uyumluluk \u00c7al\u0131\u015fmas\u0131 Yolu\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/07\/IBM-operating-principle.webp\" alt=\"\u0130la\u00e7 ama\u00e7l\u0131 HDPE kaplar i\u00e7in IBM 3 istasyonlu proses \u2014 1. istasyonda \u00f6n kal\u0131p enjeksiyonu, 2. istasyonda \u015fi\u015firme kal\u0131plama, 3. istasyonda s\u0131y\u0131rma \u2014 \u00fcretilen kaplar, Kore KFDA kimyasal uyumluluk \u00e7al\u0131\u015fmas\u0131 gerektirir. Oral s\u0131v\u0131lar i\u00e7in 12 haftal\u0131k h\u0131zland\u0131r\u0131lm\u0131\u015f 40\u00b0C 75% RH, oftalmik ila\u00e7 form\u00fclasyonlar\u0131 i\u00e7in ise 24 haftal\u0131k \u00e7al\u0131\u015fma gereklidir.\" \/><figcaption style=\"font-size: 12px; color: #64748b; margin-top: 8px; padding-left: 10px; border-left: 2px solid #d97706;\">IBM 3 istasyonlu \u00fcretim \u2014 3. istasyonda \u00fcretilen IBM konteyneri, Kore KFDA kimyasal uyumluluk testlerinde kullan\u0131lan ger\u00e7ek konteynerdir. Uyumluluk testleri, ticari \u00fcretim ko\u015fullar\u0131nda (ayn\u0131 makine, ayn\u0131 kal\u0131p seti, ayn\u0131 HDPE kalitesi, ayn\u0131 parti) ticari olarak \u00f6zde\u015f IBM konteyneri kullan\u0131larak yap\u0131lmal\u0131d\u0131r; laboratuvar \u00f6l\u00e7ekli enjeksiyon kal\u0131plama \u00f6rnekleri kullan\u0131lmamal\u0131d\u0131r.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">Kimyasal uyumluluk \u00e7al\u0131\u015fmas\u0131, Kore KFDA'n\u0131n ila\u00e7 IBM konteyner yeterlilik s\u00fcrecindeki en uzun faaliyettir ve daha iyi haz\u0131rl\u0131k, daha fazla kaynak veya daha verimli dok\u00fcmantasyon ile k\u0131salt\u0131lamayan tek faaliyettir. Tamamen, Kore KFDA taraf\u0131ndan ila\u00e7 uygulama yolu i\u00e7in belirtilen h\u0131zland\u0131r\u0131lm\u0131\u015f stabilite \u00e7al\u0131\u015fmas\u0131n\u0131n s\u00fcresine ba\u011fl\u0131d\u0131r.<\/p>\n<p><!-- compatibility timeline visual --><\/p>\n<div style=\"background: #0f1e35; border-radius: 4px; padding: 22px 26px; margin: 0 0 22px; border-top: 3px solid #d97706;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 18px;\">N\u0130TEL\u0130KLEND\u0130RME KR\u0130T\u0130K YOLU \u00b7 ORAL vs OFTALM\u0130K IBM KONTEYNER<\/p>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(min(100%,280px),1fr)); gap: 16px;\">\n<div>\n<p style=\"font-size: 11px; font-weight: bold; color: #94a3b8; margin: 0 0 12px; letter-spacing: 1px; text-transform: uppercase;\">Oral S\u0131v\u0131 \/ Kolorektal Kanser \u0130lac\u0131 (12 hafta)<\/p>\n<div style=\"display: flex; flex-direction: column; gap: 4px;\">\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">0. Hafta<\/div>\n<div style=\"flex: 1; background: #1e3a5f; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #e2e8f0;\">Makine teslimat\u0131 + ilk IBM \u00fcretim \u00f6rne\u011fi<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">1-3. Hafta<\/div>\n<div style=\"flex: 1; background: #1e3a5f; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #e2e8f0;\">KP testleri + boyutlu rapor (paralel)<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">0-12. Hafta<\/div>\n<div style=\"flex: 1; background: #d97706; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #fff; font-weight: bold;\">\u27f6 Uyumluluk \u00e7al\u0131\u015fmas\u0131 40\u00b0C \/ 75% RH (KR\u0130T\u0130K YOL)<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">12-14. Haftalar<\/div>\n<div style=\"flex: 1; background: #1e3a5f; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #e2e8f0;\">Kapan\u0131\u015f fonksiyonu testi + rapor derlemesi<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">14-16. Haftalar<\/div>\n<div style=\"flex: 1; background: #059669; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #fff; font-weight: bold;\">CTF tamamland\u0131 \u2192 Koreli ila\u00e7 markas\u0131 kalite g\u00fcvence onay\u0131<\/div>\n<\/div>\n<\/div>\n<p style=\"font-size: 11px; color: #64748b; margin: 10px 0 0;\">Toplam: \u0130lk IBM \u00fcretim \u00f6rne\u011finden itibaren yakla\u015f\u0131k 16 hafta<\/p>\n<\/div>\n<div>\n<p style=\"font-size: 11px; font-weight: bold; color: #94a3b8; margin: 0 0 12px; letter-spacing: 1px; text-transform: uppercase;\">Oftalmolojik (24 hafta \u2014 KFDA gereklili\u011fi)<\/p>\n<div style=\"display: flex; flex-direction: column; gap: 4px;\">\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">0. Hafta<\/div>\n<div style=\"flex: 1; background: #1e3a5f; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #e2e8f0;\">Makine teslimat\u0131 + ilk IBM \u00fcretim \u00f6rne\u011fi<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">1-3. Hafta<\/div>\n<div style=\"flex: 1; background: #1e3a5f; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #e2e8f0;\">KP testleri + partik\u00fcl testi + boyut raporu<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">0-24. Haftalar<\/div>\n<div style=\"flex: 1; background: #dc2626; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #fff; font-weight: bold;\">\u27f6 Uyumluluk \u00e7al\u0131\u015fmas\u0131 40\u00b0C \/ 75% RH (KR\u0130T\u0130K YOL)<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">24-26. Haftalar<\/div>\n<div style=\"flex: 1; background: #1e3a5f; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #e2e8f0;\">Damlatma kapa\u011f\u0131 fonksiyon testi + rapor derlemesi<\/div>\n<\/div>\n<div style=\"display: flex; align-items: center; gap: 8px;\">\n<div style=\"width: 80px; flex-shrink: 0; font-size: 11px; color: #64748b; text-align: right;\">26-28. Haftalar<\/div>\n<div style=\"flex: 1; background: #059669; border-radius: 2px; padding: 6px 10px; font-size: 12px; color: #fff; font-weight: bold;\">CTF tamamland\u0131 \u2192 Koreli ila\u00e7 markas\u0131 kalite g\u00fcvence onay\u0131<\/div>\n<\/div>\n<\/div>\n<p style=\"font-size: 11px; color: #64748b; margin: 10px 0 0;\">Toplam: \u0130lk IBM \u00fcretim \u00f6rne\u011finden itibaren yakla\u015f\u0131k 28 hafta<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 14px;\">Kore KFDA'n\u0131n uyumluluk \u00e7al\u0131\u015fmas\u0131 protokol\u00fc \u015funlar\u0131 gerektirir: Tam olarak ticari farmas\u00f6tik form\u00fclasyonla (yerine ge\u00e7en veya seyreltilmi\u015f \u00e7\u00f6zelti de\u011fil) ama\u00e7lanan dolum hacminde doldurulmu\u015f IBM kaplar\u0131; 40\u00b0C \u00b1 2\u00b0C \/ 75% RH \u00b1 5% RH'de saklama (Kore KFDA h\u0131zland\u0131r\u0131lm\u0131\u015f stabilite ko\u015fulu); ekstraksiyon analizi ve form\u00fclasyon tayini i\u00e7in uyumluluk biti\u015f noktas\u0131nda (12 veya 24 hafta) \u00f6rnekleme. Doldurulmu\u015f stabilite \u00f6rne\u011finden elde edilen ekstraksiyon analizi, HDPE veya PP IBM kab\u0131ndaki t\u00fcm ekstraksiyon maddelerinin, ilgili farmas\u00f6tik uygulama yolu i\u00e7in Kore KFDA toksikolojik endi\u015fe e\u015fi\u011finin (TTC) alt\u0131nda oldu\u011funu do\u011frulamal\u0131d\u0131r \u2014 oral yol TTC: bile\u015fik ba\u015f\u0131na 1,5 \u03bcg\/g\u00fcn; oftalmik yol TTC: bile\u015fik ba\u015f\u0131na 0,15 \u03bcg\/g\u00fcn (oftalmik yol i\u00e7in 10 kat daha kat\u0131).<\/p>\n<p style=\"font-size: 16px; margin-bottom: 0;\">IBM'in s\u0131f\u0131r fla\u015f \u00fcretimi, do\u011frudan bir ekstraksiyon riski azaltma avantaj\u0131d\u0131r: EBM fla\u015f kesme i\u015flemleri, dolum s\u0131ras\u0131nda kapta mevcut olmas\u0131 durumunda uyumluluk \u00e7al\u0131\u015fmas\u0131nda ekstraksiyon y\u00fck\u00fcn\u00fc art\u0131ran oksitlenmi\u015f HDPE kal\u0131nt\u0131lar\u0131 \u00fcretir. Herhangi bir kesme i\u015flemi olmadan \u00fcretilen IBM kaplar\u0131, \u00f6nemli \u00f6l\u00e7\u00fcde daha temiz bir kap i\u00e7i sunar; bu durum, Koreli ila\u00e7 m\u00fc\u015fterisi ekstraksiyon verilerinde, ayn\u0131 duvar kal\u0131nl\u0131\u011f\u0131ndaki ayn\u0131 HDPE re\u00e7ine s\u0131n\u0131f\u0131ndan EBM kaplar\u0131na k\u0131yasla s\u00fcrekli olarak daha d\u00fc\u015f\u00fck KMnO\u2084 t\u00fcketimi (organik ekstraksiyon g\u00f6stergesi) olarak g\u00f6sterilmi\u015ftir. <a style=\"color: #1e3a5f; font-weight: 600; text-decoration: none;\" href=\"https:\/\/isbm-blow-molding.com\/tr\/hdpe-injection-blow-molding\/\">HDPE IBM i\u015fleme k\u0131lavuzu<\/a> Bu metin, Kore ila\u00e7 end\u00fcstrisinde kullan\u0131lan HDPE IBM kaplar\u0131nda KMnO\u2084 t\u00fcketiminin artmas\u0131na katk\u0131da bulunan termal bozunma \u00fcr\u00fcnlerini en aza indiren varil s\u0131cakl\u0131\u011f\u0131 ve i\u015fleme ko\u015fullar\u0131n\u0131 kapsamaktad\u0131r.<\/p>\n<\/section>\n<p><!-- \u2550\u2550 S6 \u2550\u2550 --><\/p>\n<section id=\"s6\" style=\"margin: 56px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 06<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Kapanma Fonksiyonu ve Boyutsal Yeterlilik<\/h2>\n<\/div>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">Kapatma fonksiyonu yeterlilik testi, ticari \u00fcretimde belirtilen bo\u015fluk say\u0131s\u0131 ve \u00fcretim ko\u015fullar\u0131nda \u00fcretilen IBM kaplar\u0131n\u0131n, hem IBM kab\u0131n\u0131n boyun k\u0131sm\u0131n\u0131n hem de Kore kapatma bile\u015feninin t\u00fcm boyut tolerans aral\u0131\u011f\u0131 boyunca, belirlenen Kore ila\u00e7 kapatma sistemiyle do\u011fru \u015fekilde temas etti\u011fini do\u011frular. Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA), her ila\u00e7 \u00fcr\u00fcn\u00fc i\u00e7in birincil kap teknik dosyas\u0131n\u0131n bir par\u00e7as\u0131 olarak kapatma fonksiyonu yeterlilik verilerini talep etmektedir.<\/p>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(min(100%,270px),1fr)); gap: 14px; margin: 0 0 22px;\">\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-radius: 4px; overflow: hidden;\">\n<div style=\"background: #0f1e35; padding: 11px 16px; display: flex; align-items: center; gap: 8px;\"><span style=\"background: #d97706; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 7px; border-radius: 2px;\">CRC<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff;\">\u00c7ocuk Kilidi Testi<\/span><\/div>\n<div style=\"padding: 16px 18px;\">\n<p style=\"font-size: 10px; font-weight: bold; color: #475569; margin: 0 0 8px; letter-spacing: 1px;\">STANDART: KS M ISO 8317<\/p>\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 6px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>200 yeti\u015fkin denek \u2014 5 dakika i\u00e7inde \u2265 85% a\u00e7\u0131lma oran\u0131 (yeti\u015fkin eri\u015filebilirlik kriteri)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>200 \u00e7ocuk denek \u2014 10 dakika i\u00e7inde \u2264 20% a\u00e7\u0131lma oran\u0131 (\u00e7ocuk direnci kriteri)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>IBM boyun d\u0131\u015f \u00e7ap\u0131 \u00b10,05 mm kritik \u00f6neme sahiptir \u2014 \u00b10,06 mm aral\u0131\u011f\u0131nda kaynak diki\u015fi giri\u015fimi gereklidir.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Kal\u0131p setindeki t\u00fcm bo\u015fluklardan al\u0131nan yeterlilik kaplar\u0131 \u00f6rneklenmi\u015ftir.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-radius: 4px; overflow: hidden;\">\n<div style=\"background: #0f1e35; padding: 11px 16px; display: flex; align-items: center; gap: 8px;\"><span style=\"background: #d97706; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 7px; border-radius: 2px;\">\u0130ND\u00dcKS\u0130YON<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff;\">\u0130nd\u00fcksiyon Conta B\u00fct\u00fcnl\u00fc\u011f\u00fc Testi<\/span><\/div>\n<div style=\"padding: 16px 18px;\">\n<p style=\"font-size: 10px; font-weight: bold; color: #475569; margin: 0 0 8px; letter-spacing: 1px;\">STANDART: ASTM F2096<\/p>\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 6px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Pozitif bas\u0131n\u00e7 kabarc\u0131k testi: Kapal\u0131 kab\u0131 10 kPa'ya kadar \u015fi\u015firin - s\u0131zd\u0131rmazl\u0131k b\u00f6lgesinden kabarc\u0131k \u00e7\u0131k\u0131\u015f\u0131 olmamal\u0131.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>IBM boyun s\u0131zd\u0131rmazl\u0131k y\u00fczeyinin d\u00fczl\u00fc\u011f\u00fc \u2264 0,1 mm TIR, t\u00fcm bo\u015fluklarda tutarl\u0131 folyo yap\u0131\u015fmas\u0131 i\u00e7in gereklidir.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>100% numune b\u00fct\u00fcnl\u00fc\u011f\u00fc: t\u00fcm bo\u015fluklardaki t\u00fcm kaplar\u0131n yeterlilik testinden ge\u00e7mesi gerekir.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Da\u011f\u0131t\u0131m sonras\u0131 sim\u00fclasyon: ISTA 2A ko\u015fulland\u0131rmas\u0131ndan sonra tekrarlay\u0131n.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-radius: 4px; overflow: hidden;\">\n<div style=\"background: #0f1e35; padding: 11px 16px; display: flex; align-items: center; gap: 8px;\"><span style=\"background: #d97706; color: #fff; font-size: 9px; font-weight: 800; padding: 2px 7px; border-radius: 2px;\">DAMLALIK<\/span><br \/>\n<span style=\"font-size: 12px; font-weight: bold; color: #fff;\">Oftalmik Damlal\u0131k Kapa\u011f\u0131 Fonksiyonu<\/span><\/div>\n<div style=\"padding: 16px 18px;\">\n<p style=\"font-size: 10px; font-weight: bold; color: #475569; margin: 0 0 8px; letter-spacing: 1px;\">KOREAN KFDA OFTALM\u0130K SPES\u0130F\u0130KASYONU<\/p>\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 6px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Damla hacmi: Kore'ye \u00f6zel oftalmik damlal\u0131k aparat\u0131 kullan\u0131larak 23\u00b0C'de damla ba\u015f\u0131na 25\u201335 \u03bcl.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Damlal\u0131k kapa\u011f\u0131n\u0131n yerinde kalmas\u0131: Kapak yerinden \u00e7\u0131kmadan 10 N eksenel \u00e7ekme kuvveti (Koreli eczac\u0131 taraf\u0131ndan yap\u0131lan kullan\u0131m testi)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>IBM i\u00e7 \u00e7ap\u0131 \u00b10,04 mm, damla hacmini kontrol eder \u2014 nominal ve tolerans s\u0131n\u0131rlar\u0131nda test edilmi\u015ftir.<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #d97706; font-weight: bold; flex-shrink: 0;\">\u25b8<\/span>Test edilen t\u00fcm bo\u015fluklar: IBM'in 20-30 \u00fcretim bo\u015flu\u011funun her birinden en az 200 kap.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p><!-- \u2550\u2550 S7 \u2550\u2550 --><\/p>\n<section id=\"s7\" style=\"margin: 56px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 07<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Kore KFDA De\u011fi\u015fiklik Bildirim S\u00fcreci<\/h2>\n<\/div>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">Kore \u0130la\u00e7 \u0130\u015fleri Kanunu'nun 32. maddesi ve ilgili \u0130la\u00e7 \u00dcretimi ve Kalite Y\u00f6netimi Standartlar\u0131 Bildirimi ile d\u00fczenlenen Kore KFDA ila\u00e7 ambalaj\u0131 de\u011fi\u015fikli\u011fi bildirim s\u00fcreci, birincil ambalaj de\u011fi\u015fikliklerini k\u00fc\u00e7\u00fck de\u011fi\u015fiklikler (kendili\u011finden beyan edilebilir) ve b\u00fcy\u00fck de\u011fi\u015fiklikler (KFDA incelemesi gerektiren) olarak s\u0131n\u0131fland\u0131r\u0131r. Bu s\u0131n\u0131fland\u0131rma, Koreli ila\u00e7 markalar\u0131n\u0131n ambalaj de\u011fi\u015fikli\u011fi proje planlar\u0131na dahil etmeleri gereken zaman \u00e7izelgesini belirler.<\/p>\n<p><!-- change classification cards --><\/p>\n<div style=\"display: grid; grid-template-columns: repeat(auto-fit,minmax(min(100%,280px),1fr)); gap: 14px; margin: 0 0 22px;\">\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-top: 3px solid #059669; border-radius: 4px; padding: 18px 20px;\">\n<div style=\"display: flex; align-items: center; gap: 8px; margin-bottom: 14px;\"><span style=\"background: #059669; color: #fff; font-size: 9px; font-weight: 800; padding: 3px 8px; border-radius: 2px;\">K\u00dc\u00c7\u00dcK DE\u011e\u0130\u015e\u0130KL\u0130K<\/span><br \/>\n<span style=\"font-size: 11px; color: #059669; font-weight: bold;\">\u00d6z Beyan \u00b7 An\u0131nda<\/span><\/div>\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 8px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #059669; font-weight: bold; flex-shrink: 0;\">\u2713<\/span>Ayn\u0131 HDPE veya PP kalitesi, farkl\u0131 re\u00e7ine partisi (ayn\u0131 MI aral\u0131\u011f\u0131, ayn\u0131 katk\u0131 maddesi paketi)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #059669; font-weight: bold; flex-shrink: 0;\">\u2713<\/span>Orijinal tolerans spesifikasyonu dahilinde boyut de\u011fi\u015fikli\u011fi (\u00e7izimde revizyon gerekmez)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #059669; font-weight: bold; flex-shrink: 0;\">\u2713<\/span>Ayn\u0131 opak\/yar\u0131 saydam kategori i\u00e7indeki renk de\u011fi\u015fimi (KFDA onayl\u0131 renklendirici listesi)<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #059669; font-weight: bold; flex-shrink: 0;\">\u2713<\/span>\u00dcretim yeri de\u011fi\u015fikli\u011fi (ayn\u0131 konteyner \u00f6zellikleri, farkl\u0131 Koreli IBM \u00fcreticisi)<\/li>\n<\/ul>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-top: 3px solid #dc2626; border-radius: 4px; padding: 18px 20px;\">\n<div style=\"display: flex; align-items: center; gap: 8px; margin-bottom: 14px;\"><span style=\"background: #dc2626; color: #fff; font-size: 9px; font-weight: 800; padding: 3px 8px; border-radius: 2px;\">B\u00dcY\u00dcK DE\u011e\u0130\u015e\u0130KL\u0130K<\/span><br \/>\n<span style=\"font-size: 11px; color: #dc2626; font-weight: bold;\">KFDA \u0130ncelemesi \u00b7 3-6 Ay<\/span><\/div>\n<ul style=\"margin: 0; padding-left: 0; list-style: none; display: flex; flex-direction: column; gap: 8px;\">\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #dc2626; font-weight: bold; flex-shrink: 0;\">\u2717<\/span>IBM makine modeli de\u011fi\u015fikli\u011fi (ZQ80 \u2192 ZQ110) \u2014 CTF'de yeni makine seri numaras\u0131<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #dc2626; font-weight: bold; flex-shrink: 0;\">\u2717<\/span>\u00c7\u00fcr\u00fck say\u0131s\u0131 de\u011fi\u015fimi (20 \u2192 24 \u00e7\u00fcr\u00fck) \u2014 yeni boyutsal yeterlilik gereklidir<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #dc2626; font-weight: bold; flex-shrink: 0;\">\u2717<\/span>Re\u00e7ine s\u0131n\u0131f\u0131 de\u011fi\u015fikli\u011fi \u2014 yeni KP testleri ve uyumluluk \u00e7al\u0131\u015fmas\u0131 gerekiyor<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #dc2626; font-weight: bold; flex-shrink: 0;\">\u2717<\/span>Konteyner tipi de\u011fi\u015fikli\u011fi (\u00f6rne\u011fin otoklav i\u00e7in HDPE \u2192 PP) \u2014 tam yeniden yeterlilik de\u011ferlendirmesi<\/li>\n<li style=\"font-size: 14px; color: #374151; display: flex; align-items: baseline; gap: 8px;\"><span style=\"color: #dc2626; font-weight: bold; flex-shrink: 0;\">\u2717<\/span>Boyun kaplamas\u0131nda de\u011fi\u015fiklik (farkl\u0131 GPI di\u015f veya \u00e7ap) \u2014 kapatma sisteminin yeniden kalifikasyonu<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div style=\"background: #fff; border: 1px solid #e2e8f0; border-left: 4px solid #1e3a5f; padding: 16px 20px; border-radius: 0 4px 4px 0; margin: 0 0 16px;\">\n<p style=\"font-size: 13.5px; color: #374151; margin: 0; line-height: 1.7;\"><strong style=\"color: #0f1e35;\">\u00c7ift makine ile kalifikasyon \u2014 kritik planlama stratejisi:<\/strong> Koreli ila\u00e7 sekt\u00f6r\u00fc IBM \u00fcreticileri, ilk konteyner teknik dosyas\u0131nda ayn\u0131 anda iki ZQ modelini (\u00f6rne\u011fin ZQ80 seri numaras\u0131 #001 ve ZQ110 seri numaras\u0131 #002) onaylatt\u0131klar\u0131nda, ek olarak m\u00fctevaz\u0131 bir dok\u00fcmantasyon maliyeti (ikinci makine boyut raporu, ikinci makine kurulum dok\u00fcmantasyonu) \u00f6derler, ancak ZQ110'un \u00f6l\u00e7eklendirilmi\u015f \u00fcretime ge\u00e7mesiyle 3-6 ayl\u0131k KFDA b\u00fcy\u00fck de\u011fi\u015fiklik incelemesini tamamen ortadan kald\u0131r\u0131rlar. Bir b\u00fcy\u00fck de\u011fi\u015fiklik bildirim incelemesinden ka\u00e7\u0131nman\u0131n sa\u011flad\u0131\u011f\u0131 toplam maliyet tasarrufu (\u00fcretim gecikme maliyetleri, d\u00fczenleyici kaynak maliyetleri ve Kore ila\u00e7 markas\u0131 i\u00e7in f\u0131rsat maliyetleri a\u00e7\u0131s\u0131ndan), \u00e7ift makine onay dok\u00fcmantasyon maliyetini s\u00fcrekli olarak 10-20 kat a\u015fmaktad\u0131r. Korea Ever-Power, proje lansman\u0131ndan sonraki 5 y\u0131l i\u00e7inde ilk makinenin y\u0131ll\u0131k kapasitesinin \u00fczerinde \u00f6l\u00e7eklendirme \u00f6ng\u00f6r\u00fclen t\u00fcm Kore ila\u00e7 sekt\u00f6r\u00fc IBM projeleri i\u00e7in \u00e7ift makine onay\u0131n\u0131 standart uygulama olarak \u00f6nermektedir.<\/p>\n<\/div>\n<\/section>\n<p><!-- \u2550\u2550 S8 \u2550\u2550 --><\/p>\n<section id=\"s8\" style=\"margin: 56px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 22px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #fff; border: 1px solid #e2e8f0; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">B\u00d6L\u00dcM 08<\/p>\n<h2 style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #0f1e35; margin: 0; line-height: 1.2;\">Kore Ever-Power GMP Dok\u00fcmantasyon Destek Paketi<\/h2>\n<\/div>\n<\/div>\n<figure style=\"margin: 0 0 24px;\"><img decoding=\"async\" style=\"width: 100%; height: auto; border-radius: 3px; display: block; border: 1px solid #cbd5e0;\" title=\"Kore Ever-Power \u00c7al\u0131\u015ftay\u0131 \u2014 \u0130la\u00e7 Sekt\u00f6r\u00fc GMP Dok\u00fcmantasyon Deste\u011fi\" src=\"https:\/\/isbm-blow-molding.com\/wp-content\/uploads\/2026\/07\/ever-power-workshop-1.webp\" alt=\"Kore Ever-Power IBM makine imalat at\u00f6lyesi \u2014 Kore KFDA ila\u00e7 ambalaj\u0131 teknik dosyas\u0131nda ve GMP dok\u00fcmantasyon paketinde yer alan, her bir ambalaj\u0131n boyutsal yeterlilik verilerini i\u00e7eren, ila\u00e7 sekt\u00f6r\u00fcne y\u00f6nelik IBM makinelerinin teslimat \u00f6ncesi \u00fcretim denemesi.\" \/><figcaption style=\"font-size: 12px; color: #64748b; margin-top: 8px; padding-left: 10px; border-left: 2px solid #d97706;\">Korea Ever-Power'\u0131n \u00fcretim tesisinde, ila\u00e7 sekt\u00f6r\u00fcnde kullan\u0131lan IBM makineleri, m\u00fc\u015fterinin kal\u0131p seti tak\u0131l\u0131yken teslimat \u00f6ncesi \u00fcretim denemelerinden ge\u00e7irilerek, Kore KFDA ila\u00e7 kab\u0131 yeterlilik teknik dosyas\u0131n\u0131n temelini olu\u015fturan, kal\u0131p baz\u0131nda boyut verileri elde ediliyor. Bu teslimat \u00f6ncesi yeterlilik deste\u011fi, makine Kore fabrikas\u0131na ula\u015fmadan \u00f6nce do\u011frulanm\u0131\u015f \u00fcretim boyut verilerini sa\u011flayarak Koreli m\u00fc\u015fterinin yerinde yeterlilik s\u00fcrecini k\u0131salt\u0131yor.<\/figcaption><\/figure>\n<p style=\"font-size: 16px; margin-bottom: 20px;\">Korea Ever-Power, her ila\u00e7 \u00fcretim IBM makinesi ve kal\u0131p seti teslimat\u0131nda standartla\u015ft\u0131r\u0131lm\u0131\u015f bir GMP dok\u00fcmantasyon destek paketi sunmaktad\u0131r. Bu paket, Korea Ever-Power'\u0131n \u00fcretim tesisinde \u00fcretebilece\u011fi dok\u00fcmantasyon bile\u015fenlerini sa\u011flamak \u00fczere tasarlanm\u0131\u015ft\u0131r; Kore ila\u00e7 markas\u0131n\u0131n form\u00fclasyonu ve Kore kapak tedarik\u00e7isi verilerini gerektiren bile\u015fenler, CTF \u00e7er\u00e7evesinde m\u00fc\u015fteri taraf\u0131ndan sa\u011flanan \u00f6\u011feler olarak ayr\u0131 olarak tan\u0131mlanm\u0131\u015ft\u0131r.<\/p>\n<p><!-- documentation package summary table --><\/p>\n<div style=\"overflow-x: auto; margin: 0 0 22px;\">\n<table style=\"width: 100%; border-collapse: collapse; font-size: 13px; min-width: 560px;\">\n<thead>\n<tr style=\"background: #0f1e35;\">\n<th style=\"color: #f59e0b; padding: 11px 12px; text-align: left; font-weight: bold; border-right: 1px solid #1e3a5f;\">BELGELEND\u0130RME \u00d6\u011eES\u0130<\/th>\n<th style=\"color: #e2e8f0; padding: 11px 10px; text-align: center; font-weight: bold; border-right: 1px solid #1e3a5f;\">SA\u011eLAYAN<\/th>\n<th style=\"color: #e2e8f0; padding: 11px 10px; text-align: center; font-weight: bold; border-right: 1px solid #1e3a5f;\">TESL\u0130MAT ZAMANLAMASI<\/th>\n<th style=\"color: #e2e8f0; padding: 11px 10px; text-align: left; font-weight: bold;\">NOTLAR<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr style=\"background: #fff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Makine tan\u0131mlama belgesi (seri no., model, \u00f6zellikler)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; color: #059669; font-weight: bold;\">KEP<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center;\">Makine teslimat\u0131nda<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">\u00d6n yeterlilik onay\u0131 al\u0131nm\u0131\u015fsa, \u00e7ift makine sertifikalar\u0131 da dahildir.<\/td>\n<\/tr>\n<tr style=\"background: #f8fafc;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Kal\u0131p seti teknik \u00f6zellikleri (kavite say\u0131s\u0131, malzeme, yerle\u015fim)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; color: #059669; font-weight: bold;\">KEP<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center;\">Kal\u0131p teslimat\u0131nda<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">S136 paslanmaz \u00e7elik i\u00e7 bo\u015fluk malzemesi sertifikas\u0131 dahildir.<\/td>\n<\/tr>\n<tr style=\"background: #fff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Do\u011fum \u00f6ncesi, her bir bo\u015fluk i\u00e7in ayr\u0131 ayr\u0131 boyutland\u0131rma raporu (500 \u015fi\u015fe)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; color: #059669; font-weight: bold;\">KEP<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center;\">Sevkiyat \u00f6ncesi<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569; font-weight: 600;\">Benzersiz KEP hizmeti \u2014 Koreli m\u00fc\u015fterilerin yerinde yeterlilik de\u011ferlendirme s\u00fcresini k\u0131salt\u0131r.<\/td>\n<\/tr>\n<tr style=\"background: #f8fafc;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Konteynerin boyutland\u0131r\u0131lm\u0131\u015f \u00e7izimi (t\u00fcm boyutlar, toleranslar)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; color: #059669; font-weight: bold;\">KEP<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center;\">Kal\u0131p onay\u0131 a\u015famas\u0131nda<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">Kore KFDA CTF s\u00fcr\u00fcm y\u00f6netimi i\u00e7in kontroll\u00fc belge numaras\u0131<\/td>\n<\/tr>\n<tr style=\"background: #fff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">IBM proses parametre kayd\u0131 (standart \u00fcretim ko\u015fullar\u0131)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; color: #059669; font-weight: bold;\">KEP<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center;\">Do\u011fum \u00f6ncesi deneme ile<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">Varil s\u0131cakl\u0131klar\u0131, enjeksiyon bas\u0131nc\u0131, \u00fcfleme bas\u0131nc\u0131, \u00e7evrim s\u00fcresi; Kore GMP ana proses kay\u0131tlar\u0131n\u0131n temelini olu\u015fturur.<\/td>\n<\/tr>\n<tr style=\"background: #f8fafc;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Kore Farmakopesi plastik kap testi (KP ekstrakte edilebilir maddeler)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; color: #d97706; font-weight: bold;\">M\u00fc\u015fteri (Kore laboratuvar\u0131)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center;\">1-4. Haftalar<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) onayl\u0131 laboratuvar; KEP, IBM konteyner \u00f6rnekleri sa\u011flamaktad\u0131r.<\/td>\n<\/tr>\n<tr style=\"background: #fff;\">\n<td style=\"padding: 9px 12px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; font-weight: 600;\">Kimyasal uyumluluk \u00e7al\u0131\u015fmas\u0131 (doldurulmu\u015f stabilite, 12 veya 24 hafta)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center; color: #d97706; font-weight: bold;\">M\u00fc\u015fteri (Koreli ila\u00e7 markas\u0131)<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; border-right: 1px solid #e2e8f0; text-align: center;\">0-12. Haftalar \/ 0-24. Haftalar<\/td>\n<td style=\"padding: 9px 10px; border-bottom: 1px solid #e2e8f0; font-size: 12px; color: #475569;\">Kritik yol \u2014 ilk IBM \u00fcretim \u00f6rneklerinin al\u0131nmas\u0131ndan hemen sonra ba\u015flay\u0131n<\/td>\n<\/tr>\n<tr style=\"background: #f8fafc;\">\n<td style=\"padding: 9px 12px; border-right: 1px solid #e2e8f0; font-weight: 600;\">Kapak fonksiyon testi (CRC \/ ind\u00fcksiyon contas\u0131 \/ damlal\u0131kl\u0131 kapak)<\/td>\n<td style=\"padding: 9px 10px; border-right: 1px solid #e2e8f0; text-align: center; color: #d97706; font-weight: bold;\">M\u00fc\u015fteri (Koreli ila\u00e7 markas\u0131)<\/td>\n<td style=\"padding: 9px 10px; border-right: 1px solid #e2e8f0; text-align: center;\">12-14. Haftalar<\/td>\n<td style=\"padding: 9px 10px; font-size: 12px; color: #475569;\">KEP teslimat \u00f6ncesi raporu, kapan\u0131\u015f taahh\u00fcd\u00fc do\u011frulamas\u0131 i\u00e7in referans boyutsal temel verileri sa\u011flar.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<p style=\"font-size: 16px; margin-bottom: 0;\">Korea Ever-Power'\u0131n teslimat \u00f6ncesi \u00fcretim denemesi ve dok\u00fcmantasyon paketi, Koreli ila\u00e7 IBM m\u00fc\u015fterisinin yerinde kalifikasyon s\u00fcresini, tipik 24-28 haftadan (makine tesliminden CTF'nin tamamlanmas\u0131na kadar) oral ila\u00e7 kaplar\u0131 i\u00e7in yakla\u015f\u0131k 16-20 haftaya ve oftalmik kaplar i\u00e7in 26-28 haftaya d\u00fc\u015f\u00fcrmektedir; kalan s\u00fcre tamamen uyumluluk \u00e7al\u0131\u015fmas\u0131n\u0131n s\u00fcresine ba\u011fl\u0131d\u0131r ve dok\u00fcmantasyon verimlili\u011finden ba\u011f\u0131ms\u0131z olarak k\u0131salt\u0131lamaz. Korea Ever-Power'\u0131n GMP dok\u00fcmantasyon paketini proje planlama a\u015famas\u0131ndan itibaren entegre eden Koreli ila\u00e7 IBM projeleri, her bir uygulama yolu i\u00e7in m\u00fcmk\u00fcn olan en k\u0131sa s\u00fcrede Kore ila\u00e7 markas\u0131 kalite g\u00fcvence onay\u0131n\u0131 tutarl\u0131 bir \u015fekilde almaktad\u0131r. GMP dok\u00fcmantasyon paketiyle ilgili sorular, t\u00fcm ila\u00e7 IBM projeleri i\u00e7in sipari\u015f \u00f6ncesi dan\u0131\u015fma a\u015famas\u0131nda proje zaman \u00e7izelgesi plan\u0131 ve CTF kontrol listesi sa\u011flayan Korea Ever-Power'\u0131n ila\u00e7 uygulama ekibine y\u00f6nlendirilmelidir. Malzemeye \u00f6zg\u00fc kalifikasyon gereksinimleri i\u00e7in, ila\u00e7 IBM k\u0131lavuzu HDPE ve PP kap formatlar\u0131n\u0131 t\u00fcm ayr\u0131nt\u0131lar\u0131yla kapsamaktad\u0131r.<\/p>\n<\/section>\n<p><!-- \u2550\u2550 FAQ \u2550\u2550 --><\/p>\n<section style=\"margin: 64px 0 0;\">\n<div style=\"display: flex; align-items: stretch; gap: 0; margin-bottom: 24px;\">\n<div style=\"width: 4px; background: linear-gradient(180deg,#d97706,#f59e0b); border-radius: 2px; flex-shrink: 0;\"><\/div>\n<div style=\"padding: 10px 16px; background: #0f1e35; border-left: none; flex: 1;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 3px;\">MEVZUATLA \u0130LG\u0130L\u0130 SSS<\/p>\n<h2 id=\"faq\" style=\"font-size: clamp(17px,2.4vw,22px); font-weight: 800; color: #fff; margin: 0; line-height: 1.2;\">Kore KFDA GMP \u2014 D\u00fczenleyici M\u00fchendislik Sorular\u0131<\/h2>\n<\/div>\n<\/div>\n<div style=\"display: flex; flex-direction: column; gap: 2px;\">\n<div style=\"border: 1px solid #e2e8f0; border-radius: 4px 4px 0 0; overflow: hidden; margin-bottom: 2px;\">\n<div style=\"background: #1e3a5f; padding: 13px 18px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 10px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">Soru 01<\/span><\/p>\n<p style=\"font-size: 14px; font-weight: bold; color: #fff; margin: 0; line-height: 1.3;\">Koreli bir ila\u00e7 markas\u0131, yeni bir IBM konteyner kalifikasyonu planlarken ilk olarak hangi ad\u0131m\u0131 atmal\u0131d\u0131r?<\/p>\n<\/div>\n<div style=\"padding: 18px 20px; background: #fff;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.75;\">\u0130lk ad\u0131m, uygulama yolunu belirleyerek yeterlilik projesi i\u00e7in kritik yol zaman \u00e7izelgesini olu\u015fturmakt\u0131r; \u00e7\u00fcnk\u00fc uygulama yolu, t\u00fcm yeterlilik zaman \u00e7izelgesini y\u00f6neten uyumluluk \u00e7al\u0131\u015fmas\u0131n\u0131n s\u00fcresini belirler. A\u011f\u0131zdan al\u0131nan ila\u00e7lar i\u00e7in IBM kaplar\u0131 12 haftal\u0131k h\u0131zland\u0131r\u0131lm\u0131\u015f uyumluluk testi gerektirirken, oftalmik kaplar 24 hafta gerektirir. Yeterlilik projesi plan\u0131, uyumluluk \u00e7al\u0131\u015fmas\u0131n\u0131n ba\u015flang\u0131\u00e7 \u200b\u200btarihi sabit bir referans noktas\u0131 olarak al\u0131narak, gerekli ticari \u00fcretim tarihinden geriye do\u011fru olu\u015fturulmal\u0131d\u0131r. Uyumluluk \u00e7al\u0131\u015fmas\u0131, di\u011fer dok\u00fcmantasyon faaliyetleri tamamland\u0131ktan sonra de\u011fil, IBM kap \u00fcreticisinden ilk IBM \u00fcretim \u00f6rneklerinin al\u0131nd\u0131\u011f\u0131 g\u00fcn ba\u015flamal\u0131d\u0131r. Di\u011fer t\u00fcm yeterlilik faaliyetleri (KP testi, boyut raporu, kapatma fonksiyonu testi, CTF derlemesi), uyumluluk \u00e7al\u0131\u015fmas\u0131 sonucu elde edildi\u011finde CTF'nin de tamamlanm\u0131\u015f olmas\u0131 i\u00e7in uyumluluk \u00e7al\u0131\u015fmas\u0131 penceresi i\u00e7inde tamamlanacak \u015fekilde planlanmal\u0131d\u0131r. Di\u011fer faaliyetleri tamamlad\u0131ktan sonra uyumluluk \u00e7al\u0131\u015fmas\u0131na ba\u015flayan Koreli ila\u00e7 markalar\u0131, yeterlilik zaman \u00e7izelgesine gereksiz yere 3-6 hafta eklemektedir. Korea Ever-Power'\u0131n ila\u00e7 uygulamalar\u0131 ekibi, sipari\u015f \u00f6ncesi dan\u0131\u015fma a\u015famas\u0131nda t\u00fcm Koreli ila\u00e7 sekt\u00f6r\u00fc IBM m\u00fc\u015fterilerine Gantt format\u0131nda bir yeterlilik projesi zaman \u00e7izelgesi \u015fablonu sunmaktad\u0131r; bu \u015fablonda uyumluluk \u00e7al\u0131\u015fmas\u0131 sabit kritik yol \u00e7apas\u0131 olarak, di\u011fer t\u00fcm faaliyetler ise paralel \u00e7al\u0131\u015fma ak\u0131\u015flar\u0131 olarak g\u00f6sterilmektedir.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #e2e8f0; overflow: hidden; margin-bottom: 2px;\">\n<div style=\"background: #1e3a5f; padding: 13px 18px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 10px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">Soru 02<\/span><\/p>\n<p style=\"font-size: 14px; font-weight: bold; color: #fff; margin: 0; line-height: 1.3;\">HDPE re\u00e7ine tedarik\u00e7isi ayn\u0131 kalite s\u0131n\u0131f\u0131 i\u00e7inde katk\u0131 maddesi paketini de\u011fi\u015ftirdi\u011finde Kore KFDA'n\u0131n hangi belgeleri gereklidir?<\/p>\n<\/div>\n<div style=\"padding: 18px 20px; background: #fff;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.75;\">Re\u00e7ine tedarik\u00e7isinin ayn\u0131 HDPE ticari s\u0131n\u0131fland\u0131rmas\u0131 i\u00e7indeki katk\u0131 maddesi paketinde yapt\u0131\u011f\u0131 de\u011fi\u015fiklik (s\u0131n\u0131f ad\u0131 ve MI spesifikasyonu de\u011fi\u015fmeden kalsa bile), Kore KFDA ama\u00e7lar\u0131 a\u00e7\u0131s\u0131ndan \u00f6nemli bir de\u011fi\u015fiklik te\u015fkil eder, \u00e7\u00fcnk\u00fc katk\u0131 maddesi paketi orijinal ambalaj teknik dosyas\u0131nda beyan edilen re\u00e7ine bile\u015fiminin bir par\u00e7as\u0131d\u0131r. Do\u011fru Kore KFDA uygulamas\u0131, katk\u0131 maddesi de\u011fi\u015fikli\u011finin niteli\u011fine ba\u011fl\u0131d\u0131r: De\u011fi\u015fiklik, ayn\u0131 listelenen antioksidan t\u00fcr\u00fc ve y\u00fcklemesinin parti baz\u0131nda varyasyonuna (beyan edilen AO miktar\u0131n\u0131n \u00b110%'si i\u00e7inde) s\u0131n\u0131rl\u0131ysa ve re\u00e7ine tedarik\u00e7isi bunu do\u011frulayan revize edilmi\u015f bir analiz sertifikas\u0131 sunarsa, de\u011fi\u015fiklik Kore ila\u00e7 markas\u0131n\u0131n kalite g\u00fcvence ekibi taraf\u0131ndan k\u00fc\u00e7\u00fck bir de\u011fi\u015fiklik olarak beyan edilebilir. Katk\u0131 maddesi t\u00fcr\u00fc de\u011fi\u015firse (\u00f6rne\u011fin AO-1010 farkl\u0131 bir antioksidanla de\u011fi\u015ftirilirse), yeni bir antioksidan eklenirse veya AO y\u00fcklemesi beyan edilen miktar\u0131n \u00b110%'sinden fazla de\u011fi\u015firse, bu Kore KFDA'ya bildirim gerektiren ve genellikle en az\u0131ndan yeni bir Kore Farmakopesi ekstraksiyon testi ve potansiyel olarak, katk\u0131 maddesi de\u011fi\u015fikli\u011finin farmas\u00f6tik form\u00fclasyonla temas halindeki ekstraksiyon profilini etkiledi\u011fi de\u011ferlendirilirse yeni bir kimyasal uyumluluk \u00e7al\u0131\u015fmas\u0131 gerektiren \u00f6nemli bir de\u011fi\u015fikliktir. Koreli ila\u00e7 IBM \u00fcreticileri, HDPE re\u00e7ine tedarik\u00e7ilerinden t\u00fcm katk\u0131 maddesi paket de\u011fi\u015fikliklerini uygulamaya ge\u00e7meden en az 90 g\u00fcn \u00f6nce resmi yaz\u0131l\u0131 olarak bildirmelerini talep etmelidir; bu s\u00fcre, Koreli ila\u00e7 markas\u0131n\u0131n Kalite G\u00fcvence ekibinin KFDA de\u011fi\u015fiklik s\u0131n\u0131fland\u0131rmas\u0131n\u0131 de\u011ferlendirmesi ve yeni re\u00e7ine partisi \u00fcretime girmeden \u00f6nce uygun d\u00fczenleyici i\u015flemi ba\u015flatmas\u0131 i\u00e7in yeterlidir.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #e2e8f0; overflow: hidden; margin-bottom: 2px;\">\n<div style=\"background: #1e3a5f; padding: 13px 18px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 10px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">Soru 03<\/span><\/p>\n<p style=\"font-size: 14px; font-weight: bold; color: #fff; margin: 0; line-height: 1.3;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) ila\u00e7 ambalaj\u0131 yeterlilik testi Kore d\u0131\u015f\u0131nda, \u00f6rne\u011fin Korea Ever-Power'\u0131n Kore'deki tesisinde ger\u00e7ekle\u015ftirilebilir mi?<\/p>\n<\/div>\n<div style=\"padding: 18px 20px; background: #fff;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.75;\">Kore KFDA ila\u00e7 kab\u0131 yeterlilik teknik dosyas\u0131, birden fazla yerde \u00fcretilen verilerden derlenebilir; Korea Ever-Power'\u0131n boyut verileri Kore'deki Ansan-si tesisinde \u00fcretilir, Kore Farmakopesi kimyasal testleri Kore KFDA onayl\u0131 bir laboratuvarda (laboratuvar\u0131n ilgili Kore KFDA veya ICH onayl\u0131 akreditasyona sahip olmas\u0131 ko\u015fuluyla Kore i\u00e7inde veya d\u0131\u015f\u0131nda olabilir) yap\u0131l\u0131r ve uyumluluk \u00e7al\u0131\u015fmas\u0131 Koreli ila\u00e7 markas\u0131 taraf\u0131ndan Kore'deki GMP stabilite depolama tesisinde veya nitelikli bir Kore s\u00f6zle\u015fmeli ara\u015ft\u0131rma kurulu\u015funda ger\u00e7ekle\u015ftirilir. Kritik gereklilik, t\u00fcm testlerin nitelikli \u00fcretim tesisindeki nitelikli IBM makinesinde \u00fcretilen IBM kaplar\u0131n\u0131 kullanmas\u0131d\u0131r; \u00fcretim tesisi kap teknik dosyas\u0131nda belirtilmeli ve Kore KFDA kap yeterlili\u011fi bu \u00fcretim tesisine \u00f6zg\u00fc olmal\u0131d\u0131r. Bu, Koreli bir ila\u00e7 markas\u0131n\u0131n, Koreli bir IBM konteyner \u00fcreticisinden (Koreli \u00fcreticinin tesisindeki Korea Ever-Power ZQ makinesini kullanarak) bir IBM konteynerini onaylatmas\u0131 durumunda, onay konteynerlerinin Koreli IBM \u00fcreticisinin tesisinde \u00fcretilmesi gerekti\u011fi anlam\u0131na gelir; Koreli ila\u00e7 markas\u0131n\u0131n onayl\u0131 tedarik\u00e7i listesinde Korea Ever-Power do\u011frudan birincil konteyner \u00fcreticisi olarak yer almad\u0131\u011f\u0131 s\u00fcrece, Korea Ever-Power'\u0131n Ansan-si'deki tesisinde de\u011fil. Korea Ever-Power'\u0131n onay s\u00fcrecindeki rol\u00fc, makine tedarik\u00e7isi olmakt\u0131r; makineyi, kal\u0131p setini ve teslimat \u00f6ncesi boyutland\u0131rma dok\u00fcmanlar\u0131n\u0131 sa\u011flamakt\u0131r, birincil konteyner \u00fcreticisi de\u011fildir; ancak belirli bir Koreli ila\u00e7 markas\u0131, ayr\u0131 bir onayl\u0131 tedarik\u00e7i s\u00f6zle\u015fmesi kapsam\u0131nda Korea Ever-Power'\u0131 do\u011frudan birincil konteyner tedarik\u00e7isi olarak g\u00f6revlendirmi\u015fse durum farkl\u0131d\u0131r.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #e2e8f0; overflow: hidden; margin-bottom: 2px;\">\n<div style=\"background: #1e3a5f; padding: 13px 18px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 10px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">Soru 04<\/span><\/p>\n<p style=\"font-size: 14px; font-weight: bold; color: #fff; margin: 0; line-height: 1.3;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA), Kore pazar\u0131na giren jenerik ila\u00e7 \u00fcr\u00fcnleri i\u00e7in IBM konteyner yeterlilik testini nas\u0131l ele al\u0131yor?<\/p>\n<\/div>\n<div style=\"padding: 18px 20px; background: #fff;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.75;\">Kore KFDA jenerik ila\u00e7 \u00fcr\u00fcn kayd\u0131 (\uc81c\ub124\ub9ad \uc758\uc57d\ud488 \ud488\ubaa9\ud5c8\uac00), genel \u00fcr\u00fcn dosyas\u0131 sunumunun bir par\u00e7as\u0131 olarak birincil kab\u0131n nitelendirilmesini gerektirir. Kore pazar\u0131na y\u00f6nelik jenerik ila\u00e7lar i\u00e7in, e\u015fde\u011fer bir yenilik\u00e7i ila\u00e7 \u00fcr\u00fcn\u00fc belirli bir birincil kapla (\u00f6rne\u011fin 10 ml HDPE IBM kab\u0131 kullanan bir oftalmik \u00fcr\u00fcn) zaten kay\u0131tl\u0131ysa, jenerik ba\u015fvuru sahibi, biyoe\u015fde\u011fer kap performans\u0131n\u0131 g\u00f6steren birincil kap nitelendirme verilerini sunmal\u0131d\u0131r; bu veriler ayn\u0131 kap tipini (HDPE IBM, 10 ml), ayn\u0131 kapatma sistemini (ayn\u0131 damlal\u0131k kapa\u011f\u0131 GPI di\u015fli) ve referans listedeki ila\u00e7 (RLD) kab\u0131na k\u0131yasla yeni veya y\u00fcksek s\u0131zabilir bile\u015fiklerin olmad\u0131\u011f\u0131n\u0131 do\u011frulayan ekstraksiyon\/s\u0131zma verilerini i\u00e7ermelidir. Uygulamada, Koreli jenerik ila\u00e7 ba\u015fvuru sahiplerinin tam RLD kap nitelendirmesini yeniden \u00fcretmeleri gerekmez; se\u00e7tikleri IBM kab\u0131n\u0131n, nitelikli bir Koreli IBM kap \u00fcreticisi ve eksiksiz bir CTF kullanarak, RLD kab\u0131yla ayn\u0131 Kore KFDA standartlar\u0131n\u0131 kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 g\u00f6stermeleri gerekir. Korea Ever-Power'\u0131n teslimat \u00f6ncesi dok\u00fcmantasyon paketi, Koreli jenerik ila\u00e7 ba\u015fvuru sahiplerine, yenilik\u00e7i ila\u00e7 markalar\u0131na oldu\u011fu kadar verimli bir \u015fekilde hizmet vermektedir; kal\u0131p baz\u0131nda boyut raporu, makine sertifikas\u0131 ve konteyner \u00e7izimi, Kore KFDA jenerik \u00fcr\u00fcn dosya ba\u015fvurusu i\u00e7in oldu\u011fu kadar yenilik\u00e7i NDA ba\u015fvurusu i\u00e7in de ayn\u0131 kullan\u0131\u015fl\u0131l\u0131\u011fa sahiptir. Korea Ever-Power IBM konteynerleri ve standart GMP dok\u00fcmantasyon paketini kullanan Koreli jenerik ila\u00e7 projelerinde, uyumluluk \u00e7al\u0131\u015fmas\u0131n\u0131n tek kritik yol faaliyeti oldu\u011fu durumlarda, ilk IBM \u00fcretim \u00f6rne\u011finden eksiksiz ila\u00e7 dosya paketleme b\u00f6l\u00fcm\u00fcne kadar tipik bir Kore KFDA jenerik dosya haz\u0131rlama s\u00fcresi 8-14 haftad\u0131r.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #e2e8f0; overflow: hidden; margin-bottom: 2px;\">\n<div style=\"background: #1e3a5f; padding: 13px 18px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 10px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">Soru 05<\/span><\/p>\n<p style=\"font-size: 14px; font-weight: bold; color: #fff; margin: 0; line-height: 1.3;\">24 g\u00f6zl\u00fc bir IBM kal\u0131p setindeki bir g\u00f6z\u00fcn \u00f6l\u00e7\u00fclerinin belirtilen \u00f6zelliklerin d\u0131\u015f\u0131nda olmas\u0131 durumunda, Kore KFDA'n\u0131n (Kore G\u0131da ve \u0130la\u00e7 \u0130daresi) do\u011fru yakla\u015f\u0131m\u0131 nedir?<\/p>\n<\/div>\n<div style=\"padding: 18px 20px; background: #fff;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.75;\">24 bo\u015fluklu bir IBM kal\u0131p setindeki bir bo\u015fluk, kalifikasyon boyut raporunda belirtilen boyutlar\u0131n d\u0131\u015f\u0131nda bir boyut \u00fcretiyorsa, bu bo\u015fluk belirtilen boyutlara getirilene kadar kalifikasyon i\u015flemine devam edilemez; \u00e7\u00fcnk\u00fc Kore KFDA ila\u00e7 kab\u0131 kalifikasyonu, istatistiksel bir \u00f6rneklem oran\u0131 de\u011fil, t\u00fcm bo\u015fluklar\u0131n ayn\u0131 anda belirtilen boyutlar i\u00e7inde olmas\u0131n\u0131 gerektirir. Do\u011fru s\u0131ra \u015f\u00f6yledir: (1) Boyut raporundan bo\u015fluk numaras\u0131na g\u00f6re belirtilen boyutlar\u0131n d\u0131\u015f\u0131nda olan bo\u015flu\u011fu belirleyin. (2) Temel nedeni belirleyin: s\u0131cak yolluk ge\u00e7idi dengesizli\u011fi (en yayg\u0131n olan\u0131 - sistematik olarak d\u00fc\u015f\u00fck a\u011f\u0131rl\u0131kta ve d\u00fc\u015f\u00fck boyun d\u0131\u015f \u00e7ap\u0131na sahip bir bo\u015fluk \u00fcretir), bo\u015fluk ek par\u00e7as\u0131 boyut hatas\u0131 (ek par\u00e7an\u0131n yeniden i\u015flenmesini veya de\u011fi\u015ftirilmesini gerektirir) veya belirtilen boyutlar\u0131n d\u0131\u015f\u0131nda olan bo\u015flukta \u00e7ekirdek \u00e7ubuk a\u015f\u0131nmas\u0131 (d\u0131\u015f \u00e7ap nominal de\u011ferin alt\u0131ndaysa \u00e7ekirdek \u00e7ubuk muayenesi ve de\u011fi\u015ftirilmesini gerektirir). (3) Belirli bo\u015flukta d\u00fczeltici i\u015flem uygulay\u0131n: ge\u00e7it ek par\u00e7as\u0131 ayar\u0131 (ak\u0131\u015f dengesizli\u011fi i\u00e7in), bo\u015fluk ek par\u00e7as\u0131 de\u011fi\u015fimi (boyut hatas\u0131 i\u00e7in) veya \u00e7ekirdek \u00e7ubuk de\u011fi\u015fimi (a\u015f\u0131nma i\u00e7in). (4) T\u00fcm 24 bo\u015flu\u011fun ayn\u0131 anda spesifikasyon dahilinde oldu\u011funu do\u011frulamak i\u00e7in, bo\u015fluk baz\u0131nda boyut yeterlilik \u00e7al\u0131\u015fmas\u0131n\u0131 tekrarlay\u0131n \u2014 t\u00fcm 24 bo\u015flukta 500 ard\u0131\u015f\u0131k \u00fcretim d\u00f6ng\u00fcs\u00fc. (5) D\u00fczeltilmi\u015f boyut raporunu yeterlilik raporu olarak g\u00f6nderin. Kore ila\u00e7 markas\u0131n\u0131n QA ekibine, spesifikasyon d\u0131\u015f\u0131 bo\u015fluk bulgusu ve al\u0131nan d\u00fczeltici i\u015flem bildirilmelidir \u2014 bu, Kore GMP kalite sistemindeki yeterlilik sapma y\u00f6netimi dok\u00fcmantasyonunun bir par\u00e7as\u0131n\u0131 olu\u015fturur. Korea Ever-Power'\u0131n kal\u0131p m\u00fchendisli\u011fi ekibi, standart ila\u00e7 IBM kal\u0131p garantisine dahil olan teslimat sonras\u0131 bir hizmet olarak, spesifikasyon d\u0131\u015f\u0131 bo\u015fluk bulgular\u0131 i\u00e7in k\u00f6k neden analizi ve d\u00fczeltici i\u015flem deste\u011fi sa\u011flar.<\/p>\n<\/div>\n<\/div>\n<div style=\"border: 1px solid #e2e8f0; border-radius: 0 0 4px 4px; overflow: hidden; margin-bottom: 64px;\">\n<div style=\"background: #1e3a5f; padding: 13px 18px; display: flex; align-items: center; gap: 10px;\"><span style=\"background: #d97706; color: #fff; font-size: 10px; font-weight: 800; padding: 2px 8px; border-radius: 2px; flex-shrink: 0;\">Soru 06<\/span><\/p>\n<p style=\"font-size: 14px; font-weight: bold; color: #fff; margin: 0; line-height: 1.3;\">Kore G\u0131da ve \u0130la\u00e7 \u0130daresi (KFDA) ila\u00e7 kab\u0131 GMP standartlar\u0131, IBM kab\u0131n\u0131n y\u0131ll\u0131k yeniden kalifikasyonunu veya periyodik yeniden ge\u00e7erlilik testini gerektiriyor mu?<\/p>\n<\/div>\n<div style=\"padding: 18px 20px; background: #fff;\">\n<p style=\"font-size: 15px; color: #374151; margin: 0; line-height: 1.75;\">Kore KFDA ila\u00e7 konteyner GMP'si, \u00fcretimde herhangi bir de\u011fi\u015fiklik yap\u0131lmad\u0131\u011f\u0131 s\u00fcrece IBM konteynerlerinin periyodik olarak yeniden nitelendirilmesini gerektirmez; ilk nitelendirme, \u00fcretim ekipman\u0131nda (makine, kal\u0131p), malzemede (re\u00e7ine s\u0131n\u0131f\u0131, nitelikli aral\u0131k i\u00e7indeki parti) veya proses ko\u015fullar\u0131nda (nitelikli kontrol aral\u0131\u011f\u0131 i\u00e7indeki normal proses parametre varyasyonunun \u00f6tesinde) herhangi bir de\u011fi\u015fiklik yap\u0131lmad\u0131\u011f\u0131 s\u00fcrece ge\u00e7erlili\u011fini korur. Bununla birlikte, Kore GMP ila\u00e7 \u00fcreticilerinin, kalite sistemleri arac\u0131l\u0131\u011f\u0131yla konteyner kalitesini s\u00fcrekli olarak izlemeleri gerekmektedir: bo\u015fluk baz\u0131nda konteyner a\u011f\u0131rl\u0131\u011f\u0131 izleme (duvar kal\u0131nl\u0131\u011f\u0131 tutarl\u0131l\u0131\u011f\u0131n\u0131n bir g\u00f6stergesi olarak, genellikle her Kore \u00fcretim partisinin ba\u015flang\u0131c\u0131nda, ortas\u0131nda ve sonunda \u00f6rneklenir), periyodik boyun d\u0131\u015f \u00e7ap\u0131 \u00f6l\u00e7\u00fcm\u00fc (s\u0131kl\u0131k, ila\u00e7 markas\u0131n\u0131n proses yeterlilik verilerine g\u00f6re belirlenir - genellikle IBM ila\u00e7 kal\u0131plar\u0131 i\u00e7in her 500.000 d\u00f6ng\u00fcde bir) ve y\u0131ll\u0131k konteynerden s\u0131zan madde g\u00f6zetim testi (iste\u011fe ba\u011fl\u0131d\u0131r, ancak 2024'te Kore MFDS GMP denetim k\u0131lavuzu g\u00fcncellemelerinin ard\u0131ndan Kore ila\u00e7 markas\u0131 kalite g\u00fcvence ekipleri taraf\u0131ndan giderek daha fazla beklenmektedir). IBM kal\u0131p seti, Kore Ever-Power taraf\u0131ndan \u00f6nerilen yeniden parlatma aral\u0131\u011f\u0131na (ila\u00e7 kal\u0131plar\u0131 i\u00e7in 500.000 d\u00f6ng\u00fc) veya \u00e7ekirdek \u00e7ubuk de\u011fi\u015ftirme aral\u0131\u011f\u0131na (ila\u00e7 HDPE IBM i\u00e7in tipik olarak 2-3 milyon d\u00f6ng\u00fc) yakla\u015ft\u0131\u011f\u0131nda, ila\u00e7 IBM \u00fcreticisi Kore ila\u00e7 markas\u0131n\u0131n Kalite G\u00fcvence ekibini bilgilendirmelidir. Bak\u0131m aral\u0131\u011f\u0131na yakla\u015fan d\u00f6nemden elde edilen boyut izleme verileri, kab\u0131n bak\u0131m \u00f6ncesi \u00fcretim d\u00f6nemi boyunca yeterlilik spesifikasyonu dahilinde kald\u0131\u011f\u0131n\u0131 g\u00f6stermeli ve bak\u0131m sonras\u0131 ilk numune boyut do\u011frulama \u00e7al\u0131\u015fmas\u0131, ticari \u00fcretime devam etmeden \u00f6nce boyutlar\u0131n spesifikasyon dahilinde geri getirildi\u011fini do\u011frulamal\u0131d\u0131r. Bu bak\u0131m dok\u00fcmantasyonu, Kore GMP ila\u00e7 \u00fcreticisinin de\u011fi\u015fiklik kontrol kayd\u0131n\u0131n bir par\u00e7as\u0131 haline gelir; bu, Kore KFDA d\u00fczenleyici bildirimi de\u011fil, Kore MFDS GMP m\u00fcfetti\u015flerinin Kore GMP tesis denetimleri s\u0131ras\u0131nda inceleyebilece\u011fi dahili bir kalite sistem belgesidir.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p><!-- CTA --><\/p>\n<div style=\"margin: 0 0 72px; background: #0f1e35; border-radius: 4px; overflow: hidden; position: relative;\">\n<div style=\"height: 4px; background: linear-gradient(90deg,#d97706,#f59e0b,#d97706);\"><\/div>\n<div style=\"position: absolute; right: 0; top: 0; bottom: 0; width: 40%; background: linear-gradient(135deg,transparent 0%,rgba(30,58,95,0.5) 100%); pointer-events: none;\"><\/div>\n<div style=\"position: relative; padding: clamp(32px,5vw,52px) clamp(24px,4vw,48px); text-align: center;\">\n<p style=\"font-size: 9px; font-weight: 800; letter-spacing: 3px; text-transform: uppercase; color: #d97706; margin: 0 0 14px;\">\u0130LA\u00c7 SEKT\u00d6R\u00dc IBM GMP DANI\u015eMANLI\u011eI \u00b7 KOREA EVER-POWER<\/p>\n<h2 style=\"font-size: clamp(18px,3vw,28px); font-weight: 900; color: #fff; margin: 0 0 14px; letter-spacing: -0.5px;\">IBM ila\u00e7 kaplar\u0131 i\u00e7in Kore KFDA GMP kalifikasyonu planlan\u0131yor mu?<\/h2>\n<p style=\"font-size: 15px; color: #94a3b8; max-width: 520px; margin: 0 auto 28px; line-height: 1.65;\">Korea Ever-Power, her Kore ila\u00e7 sekt\u00f6r\u00fc IBM projesi i\u00e7in ila\u00e7 sekt\u00f6r\u00fcne y\u00f6nelik IBM GMP dok\u00fcmantasyon paketini (makine sertifikasyonu, kal\u0131p spesifikasyonu, teslimat \u00f6ncesi kal\u0131p baz\u0131nda boyut raporu ve \u00e7ift makine kalifikasyon deste\u011fi) sa\u011flamaktad\u0131r. \u0130la\u00e7 sekt\u00f6r\u00fc uygulama ekibimiz, sipari\u015f \u00f6ncesi dan\u0131\u015fma a\u015famas\u0131nda kalifikasyon projesi zaman \u00e7izelgesi ve CTF kontrol listesi sunmaktad\u0131r.<\/p>\n<p><a style=\"display: inline-flex; align-items: center; gap: 8px; background: #d97706; color: #fff; padding: 14px 36px; border-radius: 3px; text-decoration: none; font-weight: 800; font-size: 14px; letter-spacing: 0.5px; text-transform: uppercase;\" href=\"https:\/\/isbm-blow-molding.com\/tr\/contact-us\/\">\u0130la\u00e7 Sekt\u00f6r\u00fc i\u00e7in IBM GMP Dan\u0131\u015fmanl\u0131\u011f\u0131 Talebi <span style=\"font-size: 16px;\">\u2192<\/span><\/a><\/p>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>&nbsp; REGULATORY GUIDE \u00b7 KOREAN KFDA GMP \u00b7 IBM PHARMACEUTICAL \u00b7 KOREA EVER-POWER Korean KFDA IBM Pharmaceutical Container GMP Guide Korean KFDA pharmaceutical container GMP qualification is the critical path item in every IBM pharmaceutical packaging project in Korea \u2014 longer than machine manufacture, longer than mould production, and independent of how quickly Korea Ever-Power [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[24],"tags":[],"class_list":["post-1090","post","type-post","status-publish","format-standard","hentry","category-technical-deep-dive"],"_links":{"self":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/1090","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/comments?post=1090"}],"version-history":[{"count":1,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/1090\/revisions"}],"predecessor-version":[{"id":1092,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/posts\/1090\/revisions\/1092"}],"wp:attachment":[{"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/media?parent=1090"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/categories?post=1090"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/isbm-blow-molding.com\/tr\/wp-json\/wp\/v2\/tags?post=1090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}