{"id":17310,"date":"2026-08-09T01:32:48","date_gmt":"2026-08-09T01:32:48","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17310"},"modified":"2026-05-08T02:45:22","modified_gmt":"2026-05-08T02:45:22","slug":"sop-for-contract-manufacturing-in-pharmaceutical","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-contract-manufacturing-in-pharmaceutical\/","title":{"rendered":"\u0130la\u00e7 Sekt\u00f6r\u00fcnde Fason \u00dcretim Standart \u0130\u015f Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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\u0130la\u00e7 End\u00fcstrisinde S\u00f6zle\u015fmeli \u00dcretime \u0130li\u015fkin Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc.<\/p>

\"\u0130la\u00e7
\u0130la\u00e7 Sekt\u00f6r\u00fcnde Fason \u00dcretim i\u00e7in Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure>

1.0 AMA\u00c7:<\/strong><\/h2>

Tesisimizde fason \u00fcretim faaliyetlerinin nas\u0131l y\u00fcr\u00fct\u00fcld\u00fc\u011f\u00fcn\u00fc a\u00e7\u0131klamak. Bu, \u00fc\u00e7\u00fcnc\u00fc taraflar i\u00e7in \u00fcretilen \u00fcr\u00fcnleri ve ayr\u0131ca tesisin kendi ad\u0131na \u00fc\u00e7\u00fcnc\u00fc taraflarca \u00fcretilmesini sa\u011flad\u0131\u011f\u0131 \u00fcr\u00fcnleri kapsamaktad\u0131r. Ama\u00e7, bu d\u00fczenleme s\u00fcresince \u00fcr\u00fcn kalitesini, hasta g\u00fcvenli\u011fini ve GMP uyumlulu\u011funu sa\u011flamakt\u0131r.<\/p>

2.0 KAPSAM:<\/strong><\/h2>

Bu Prosed\u00fcr, tesisin taraf oldu\u011fu her t\u00fcrl\u00fc fason \u00fcretim anla\u015fmas\u0131n\u0131 kapsar. Tesisin S\u00f6zle\u015fme Veren ya da S\u00f6zle\u015fme Kabul Eden taraf olmas\u0131 fark etmeksizin ge\u00e7erlidir. Klinik ara\u015ft\u0131rma partileri, ticari \u00fcr\u00fcnler ve ihracat ama\u00e7l\u0131 \u00fcr\u00fcnler de bu kapsam\u0131n i\u00e7indedir.<\/p>

3.0 SORUMLULUK:<\/strong><\/h2>

S\u00f6zle\u015fmeli \u00dcretim Sorumlusu, Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc ve Mevzuat \u0130\u015fleri Sorumlusu<\/p>

4.0 SORUMLULUK:<\/strong><\/h2>

Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc ve Yetkili Ki\u015fi (QP).<\/p>

5.0 \u0130\u015eLEM:<\/strong><\/h2>

5.1 Herhangi bir fason \u00fcretim anla\u015fmas\u0131n\u0131n merkezinde iki rol yer al\u0131r. S\u00f6zle\u015fme Veren, \u00fcr\u00fcn\u00fcn ve pazarlama izninin sahibi olan taraft\u0131r. S\u00f6zle\u015fme Al\u0131c\u0131 ise \u00fcr\u00fcn\u00fc kendi tesisinde fiilen \u00fcreten taraft\u0131r.<\/p>

5.2 Her iki rol de GMP kapsam\u0131nda net y\u00fck\u00fcml\u00fcl\u00fckler ta\u015f\u0131r. S\u00f6zle\u015fme Veren, \u00fcr\u00fcn ba\u015fka biri taraf\u0131ndan \u00fcretilmi\u015f olsa bile sat\u0131lan \u00fcr\u00fcnden sorumlu olmaya devam eder. S\u00f6zle\u015fme Al\u0131c\u0131 ise s\u00f6z konusu \u00fcr\u00fcn\u00fc s\u00f6zle\u015fmede belirtilen standartlara uygun olarak \u00fcretmekle y\u00fck\u00fcml\u00fcd\u00fcr.<\/p>

5.3 Bu tesisteki her fason \u00fcretim anla\u015fmas\u0131, iki ayr\u0131 belge ile desteklenmektedir. Ticari s\u00f6zle\u015fme, fiyat, miktar ve teslimat\u0131 kapsar. Kalite Anla\u015fmas\u0131 ise her bir taraf\u0131n kaliteyle ilgili t\u00fcm y\u00fck\u00fcml\u00fcl\u00fcklerini kapsar.<\/p>

5.4 Her iki taraf\u0131n Yetkili Ki\u015fisi (QP) taraf\u0131ndan her iki belge de imzalanana kadar, hi\u00e7bir \u00fcr\u00fcn bir s\u00f6zle\u015fme kapsam\u0131nda \u00fcretilemez, sevk edilemez veya piyasaya s\u00fcr\u00fclemez.<\/p>

5.5 Yeni Bir S\u00f6zle\u015fme Orta\u011f\u0131n\u0131n De\u011ferlendirilmesi:<\/strong><\/h3>

5.5.1 Her yeni i\u015f orta\u011f\u0131, s\u00f6zle\u015fme imzalanmadan \u00f6nce bir de\u011ferlendirme s\u00fcrecinden ge\u00e7mek zorundad\u0131r. Bu durum, i\u015fin site taraf\u0131ndan veriliyor ya da al\u0131n\u0131yor olmas\u0131na bak\u0131lmaks\u0131z\u0131n her iki taraf i\u00e7in de ge\u00e7erlidir.<\/p>

5.5.2 G\u00fcvenlik incelemesi a\u015fa\u011f\u0131daki alanlar\u0131 kapsamaktad\u0131r:<\/strong><\/h4>

5.5.2.1 GMP durumu: ge\u00e7erli bir \u00fcretim ruhsat\u0131 ve gerekti\u011finde ilgili makamdan al\u0131nm\u0131\u015f ge\u00e7erli bir GMP sertifikas\u0131.<\/p>

5.5.2.2 Denetim ge\u00e7mi\u015fi: Son \u00fc\u00e7 y\u0131la ait t\u00fcm a\u00e7\u0131k d\u00fczenleyici bulgular, \u00fcr\u00fcn geri \u00e7a\u011f\u0131rma ge\u00e7mi\u015fi ve denetim sonu\u00e7lar\u0131.<\/p>

5.5.2.3 Teknik kapasite: uygun ekipman, gerekli e\u011fitimi alm\u0131\u015f personel ve planlanan hacmi kar\u015f\u0131layacak yeterli kapasite.<\/p>

5.5.2.4 Kalite sistemi: De\u011fi\u015fiklik kontrol\u00fc, sapma ve CAPA s\u00fcre\u00e7lerinin t\u00fcm\u00fcn\u00fcn y\u00fcr\u00fcrl\u00fckte oldu\u011fu, belgelenmi\u015f bir kalite y\u00f6netim sistemi.<\/p>

5.5.2.5 Mali durum: S\u00f6zle\u015fme s\u00fcresi boyunca iflas riski ta\u015f\u0131yan herhangi bir orta\u011f\u0131n varl\u0131\u011f\u0131n\u0131 d\u0131\u015flamak amac\u0131yla yap\u0131lan temel bir mali kontrol.<\/p>

5.5.3 Herhangi bir s\u00f6zle\u015fme imzalanmadan \u00f6nce yerinde denetim ger\u00e7ekle\u015ftirilir. Denetim kapsam\u0131nda, do\u011frudan g\u00f6zlem, belge incelemesi ve personel g\u00f6r\u00fc\u015fmeleri yoluyla yukar\u0131da s\u0131ralanan t\u00fcm alanlar kontrol edilir.<\/p>

5.5.4 Tedarik\u00e7i Denetim Raporu, Kalite G\u00fcvence M\u00fcd\u00fcr\u00fcne iletilir. \u201c\u00d6nemli\u201d veya \u201ckritik\u201d olarak derecelendirilen t\u00fcm bulgular\u0131n, s\u00f6zle\u015fme imzalanmadan \u00f6nce giderilmesi gerekir.<\/p>

5.5.5 G\u00fcvenlik incelemesi a\u015famas\u0131n\u0131 ge\u00e7emeyen bir i\u015f orta\u011f\u0131 reddedilir. Sat\u0131c\u0131 Denetim Raporu ve reddedilme nedeni, ileride ba\u015fvurulmak \u00fczere dosyada saklan\u0131r.<\/p>

5.6 Kalite Anla\u015fmas\u0131:<\/strong><\/h3>

5.6.1 Kalite Anla\u015fmas\u0131, iki tesiste kalitenin nas\u0131l y\u00f6netilece\u011fini belirleyen temel belgedir. Ticari s\u00f6zle\u015fmeyle birlikte yer al\u0131r, ancak ba\u015fl\u0131 ba\u015f\u0131na ayr\u0131 bir belgedir.<\/p>

5.6.2 Her Kalite Anla\u015fmas\u0131, en az\u0131ndan a\u015fa\u011f\u0131daki hususlar\u0131 i\u00e7ermelidir:<\/p>

5.6.2.1 \u0130ki taraf aras\u0131ndaki g\u00f6revlerin, bir tablo veya sorumluluk matrisi \u015feklinde net bir \u015fekilde ayr\u0131lmas\u0131.<\/p>

5.6.2.2 S\u00f6zle\u015fmenin kapsam\u0131na giren \u00fcr\u00fcn listesi; bu liste, \u00fcr\u00fcnlerin dozajlar\u0131, ambalaj boyutlar\u0131 ve pazarlar\u0131n\u0131 i\u00e7ermektedir.<\/p>

5.6.2.3 \u00dcr\u00fcn, s\u00fcre\u00e7, tesis veya tedarik\u00e7ide yap\u0131lacak de\u011fi\u015fikliklere ili\u015fkin kurallar.<\/p>

5.6.2.4 Her bir taraf\u0131n sapmalar\u0131, \u015fikayetleri, istenmeyen olaylar\u0131 ve \u00fcr\u00fcn geri \u00e7a\u011f\u0131rma i\u015flemlerini nas\u0131l ele alaca\u011f\u0131.<\/p>

5.6.2.5 Parti serbest b\u0131rakma kurallar\u0131; nihai serbest b\u0131rakma i\u00e7in imza atan Yetkili Ki\u015finin ad\u0131.<\/p>

5.6.2.6 Denetim haklar\u0131; bunlara, S\u00f6zle\u015fme Veren\u2019in makul bir bildirim s\u00fcresi i\u00e7inde S\u00f6zle\u015fme Kabul Eden\u2019in tesislerini denetleme hakk\u0131 da dahildir.<\/p>

5.6.2.7 Numune saklama kurallar\u0131: ka\u00e7 adet numune, hangi ko\u015fullarda, ne kadar s\u00fcreyle ve kimler taraf\u0131ndan saklanacak.<\/p>

5.6.2.8 Belge saklama kurallar\u0131: Hangi kay\u0131tlar\u0131 kim saklar ve ne kadar s\u00fcreyle?.<\/p>

5.6.3 Kalite Anla\u015fmas\u0131, her iki taraf\u0131n Kalite G\u00fcvence birimleri taraf\u0131ndan en az iki y\u0131lda bir g\u00f6zden ge\u00e7irilir. G\u00f6zden ge\u00e7irme, herhangi bir \u00f6nemli de\u011fi\u015fiklik veya d\u00fczenleyici \u00f6nlem nedeniyle de ba\u015flat\u0131labilir.<\/p>

5.6.4 Kalite Anla\u015fmas\u0131\u2019nda yap\u0131lan t\u00fcm de\u011fi\u015fiklikler, De\u011fi\u015fiklik Kontrol sistemi \u00fczerinden ger\u00e7ekle\u015ftirilir. Bir de\u011fi\u015fikli\u011fin y\u00fcr\u00fcrl\u00fc\u011fe girmesi i\u00e7in her iki taraf\u0131n da onay vermesi gerekir.<\/p>

5.7 Teknoloji Transferi:<\/strong><\/h3>

5.7.1 Herhangi bir parti \u00fcretilmeden \u00f6nce, \u00fcr\u00fcn S\u00f6zle\u015fme Veren taraf\u0131ndan S\u00f6zle\u015fme Al\u0131c\u0131ya devredilmelidir. Buna teknoloji transferi denir.<\/p>

5.7.2 S\u00f6zle\u015fme Veren, devrin bir par\u00e7as\u0131 olarak a\u015fa\u011f\u0131daki belgeleri teslim eder:<\/p>

5.7.2.1 Ana Kar\u0131\u015f\u0131m \u00dcretim Kayd\u0131.<\/p>

5.7.2.2 Ana Parti Paketleme Kayd\u0131.<\/p>

5.7.2.3 \u00dcr\u00fcn \u00f6zellikleri ve analitik test y\u00f6ntemleri.<\/p>

5.7.2.4 \u00dcr\u00fcne ili\u015fkin kararl\u0131l\u0131k verileri.<\/p>

5.7.2.5 Orijinal tesisten gelen s\u00fcre\u00e7 do\u011frulama raporlar\u0131.<\/p>

5.7.2.6 \u00dcr\u00fcn\u00fcn sat\u0131ld\u0131\u011f\u0131 pazarlarda yap\u0131lan d\u00fczenleyici kurum bildirimleri.<\/p>

5.7.3 S\u00f6zle\u015fme Kabul Eden Taraf, yerel bir Teknoloji Transferi Protokol\u00fc haz\u0131rlar. Bu protokol, \u00fcr\u00fcn\u00fcn yeni tesiste devreye al\u0131nmas\u0131 i\u00e7in gerekli t\u00fcm ad\u0131mlar\u0131 listeler.<\/p>

5.7.4 \u00d6ncelikle bir dizi m\u00fchendislik partisi olu\u015fturulur. Bu partiler, s\u00fcrecin S\u00f6zle\u015fme Kabul Eden Taraf\u0131n ekipman\u0131nda hatas\u0131z bir \u015fekilde \u00e7al\u0131\u015ft\u0131\u011f\u0131n\u0131 kan\u0131tlamak i\u00e7in kullan\u0131l\u0131r.<\/p>

5.7.5 M\u00fchendislik partilerinin ard\u0131ndan, tam ticari \u00f6l\u00e7ekte arka arkaya \u00fc\u00e7 do\u011frulama partisi \u00fcretilir. Her parti, kimlik, etki maddesi, \u00e7\u00f6z\u00fcnme ve ilgili maddeler a\u00e7\u0131s\u0131ndan kapsaml\u0131 bir test dizisinden ge\u00e7irilir.<\/p>

5.7.6 Teknoloji Transfer Raporu, transfer s\u00fcrecini sonland\u0131r\u0131r. Rapor, \u00fcr\u00fcn\u00fcn yeni tesiste t\u00fcm teknik \u00f6zellikleri kar\u015f\u0131lad\u0131\u011f\u0131n\u0131 ve ticari \u00fcretime haz\u0131r oldu\u011funu belirtir.<\/p>

5.8 Malzeme Tedariki:<\/strong><\/h3>

5.8.1 Kalite Anla\u015fmas\u0131\u2019nda her bir hammadde, ambalaj malzemesi ve aktif bile\u015fenin tedarik\u00e7isi belirtilir. \u00c7o\u011fu durumda, S\u00f6zle\u015fme Veren taraf aktif bile\u015feni tedarik ederken, S\u00f6zle\u015fme Kabul Eden taraf geri kalan malzemeleri temin eder.<\/p>

5.8.2 Herhangi bir etken madde tedarik\u00e7isi, S\u00f6zle\u015fme Veren taraf\u0131ndan onaylanmal\u0131d\u0131r. S\u00f6zle\u015fme Kabul Eden, resmi bir de\u011fi\u015fiklik talebi olmaks\u0131z\u0131n etken madde tedarik\u00e7isini de\u011fi\u015ftiremez.<\/p>

5.8.3 S\u00f6zle\u015fme Veren taraf\u0131ndan tedarik edilen malzemeler, her parti i\u00e7in bir analiz sertifikas\u0131 ile birlikte teslim edilir. S\u00f6zle\u015fme Al\u0131c\u0131, teslim ald\u0131\u011f\u0131nda kimlik testlerini ger\u00e7ekle\u015ftirir ancak tam serbest b\u0131rakma testlerini tekrarlamaz.<\/p>

5.8.4 S\u00f6zle\u015fme Kabul Eden Taraf taraf\u0131ndan temin edilen malzemeler, gelen mallara ili\u015fkin standart operasyon prosed\u00fcr\u00fcn\u00fcn (SOP) t\u00fcm a\u015famalar\u0131na uygun olarak i\u015flenir. Her parti i\u00e7in bir analiz sertifikas\u0131 dosyalan\u0131r.<\/p>

5.8.5 Malzeme eksikli\u011fi, 24 saat i\u00e7inde iki taraf aras\u0131nda bildirilir. Tamamlanmas\u0131 i\u00e7in yeterli malzeme bulunmayan hi\u00e7bir parti ba\u015flat\u0131lmaz.<\/p>

5.9 Seri \u00dcretim ve Denetim:<\/strong><\/h3>

5.9.1 Her parti, teknoloji transferi s\u0131ras\u0131nda devredilen Ana Parti \u00dcretim Kayd\u0131\u2019na uygun olarak \u00fcretilir. S\u00f6zle\u015fme Al\u0131c\u0131, S\u00f6zle\u015fme Veren\u2019in yaz\u0131l\u0131 onay\u0131 olmadan bu kayd\u0131 de\u011fi\u015ftiremez.<\/p>

5.9.2 \u00dcretim s\u0131ras\u0131nda S\u00f6zle\u015fme Veren taraf\u0131ndan bir Tesis \u0130\u00e7i G\u00f6revli (PIP) g\u00f6revlendirilebilir. PIP, \u00fcretilmekte olan partiyi izler ve \u00f6nemli a\u015famalarda onay verir.<\/p>

5.9.3 \u00dcretim s\u00fcrecindeki kalite kontrolleri, ana kay\u0131tta belirtildi\u011fi \u015fekilde ger\u00e7ekle\u015ftirilir. Spesifikasyon d\u0131\u015f\u0131 herhangi bir sonu\u00e7, bir sapma olarak kaydedilir ve bir i\u015f g\u00fcn\u00fc i\u00e7inde \u0130\u015fveren\u2019e bildirilir.<\/p>

5.9.4 Toplu belgeler \u00f6ncelikle S\u00f6zle\u015fme Al\u0131c\u0131s\u0131ndaki Kalite G\u00fcvence birimi taraf\u0131ndan incelenir. Ard\u0131ndan, imzalanm\u0131\u015f toplu kay\u0131t belgesinin tam bir kopyas\u0131 S\u00f6zle\u015fme Veren taraf\u0131ndaki Kalite G\u00fcvence birimine g\u00f6nderilir.<\/p>

5.9.5 Kalite kontrol testleri ve ar\u015fivleme amac\u0131yla her partiden numune al\u0131n\u0131r. Numune alma plan\u0131, Kalite Anla\u015fmas\u0131\u2019nda belirlenmi\u015ftir.<\/p>

5.10 Parti Serbest B\u0131rakma:<\/strong><\/h3>

5.10.1 Parti serbest b\u0131rakma, pazara ba\u011fl\u0131 olarak tek a\u015famal\u0131 veya iki a\u015famal\u0131 bir s\u00fcre\u00e7 olabilir.<\/p>

5.10.2 Tek a\u015famal\u0131 bir serbest b\u0131rakma i\u015flemi s\u00f6z konusu oldu\u011funda, S\u00f6zle\u015fme Kabul Eden Taraf\u2019taki Yetkili Ki\u015fi, imzalanm\u0131\u015f parti kayd\u0131 ve t\u00fcm test sonu\u00e7lar\u0131na dayanarak partiyi serbest b\u0131rak\u0131r. Bu model, basit fason \u00fcretimde yayg\u0131n olarak kullan\u0131lmaktad\u0131r.<\/p>

5.10.3 \u0130ki a\u015famal\u0131 bir onay s\u00fcrecinde, S\u00f6zle\u015fme Kabul Eden taraf teknik onay\u0131, S\u00f6zle\u015fme Veren taraf ise pazarlama onay\u0131 verir. \u00dcr\u00fcn\u00fcn herhangi bir pazara sevk edilebilmesi i\u00e7in her iki imzan\u0131n da bulunmas\u0131 gerekir.<\/p>

5.10.4 Herhangi bir test sonucu onaylanm\u0131\u015f spesifikasyonlar\u0131n d\u0131\u015f\u0131nda kal\u0131rsa, s\u00f6z konusu parti serbest b\u0131rak\u0131lmaz. Spesifikasyon d\u0131\u015f\u0131 bir sonu\u00e7, tesis sapma SOP\u2019sine g\u00f6re bir soru\u015fturma ba\u015flat\u0131r.<\/p>

5.10.5 Yetkili Ki\u015fi, imzalanm\u0131\u015f bir Serbest B\u0131rakma Karar Kay\u0131t Defteri tutar. Her parti serbest b\u0131rakma, bekletme ve reddetme karar\u0131, tarih ve gerek\u00e7e ile birlikte bu kay\u0131t defterine i\u015flenir.<\/p>

5.11 De\u011fi\u015fiklik Kontrol\u00fc:<\/strong><\/h3>

5.11.1 Her iki tesiste de \u00fcr\u00fcn kalitesini etkileyen her t\u00fcrl\u00fc de\u011fi\u015fiklik, De\u011fi\u015fiklik Kontrol sisteminden ge\u00e7melidir. Buna form\u00fclasyon, s\u00fcre\u00e7, ekipman, tesisler, teknik \u00f6zellikler ve tedarik\u00e7ilerle ilgili de\u011fi\u015fiklikler dahildir.<\/p>

5.11.2 De\u011fi\u015fiklik \u00f6neren taraf, bir De\u011fi\u015fiklik Kontrol Talebi haz\u0131rlayarak bunu inceleme amac\u0131yla di\u011fer tarafa g\u00f6nderir. Di\u011fer taraf\u0131n, 30 g\u00fcn i\u00e7inde onay, red veya ek bilgi talebiyle yan\u0131t vermesi gerekir.<\/p>

5.11.3 Bir de\u011fi\u015fiklik, her iki taraf\u0131n da onay\u0131n\u0131 alana kadar uygulamaya konulmaz. Sessiz onay, fason \u00fcretim i\u015fleri i\u00e7in ge\u00e7erli de\u011fildir.<\/p>

5.11.4 De\u011fi\u015fikliklere ili\u015fkin d\u00fczenleyici kurumlara yap\u0131lan ba\u015fvurular, Kalite Anla\u015fmas\u0131\u2019nda ad\u0131 ge\u00e7en taraf\u00e7a y\u00fcr\u00fct\u00fcl\u00fcr. \u00c7o\u011fu durumda bu taraf, pazarlama izni sahibi olarak S\u00f6zle\u015fme Veren\u2019dir.<\/p>

5.11.5 Acil durumlarda, yaz\u0131l\u0131 onay al\u0131nmadan de\u011fi\u015fiklikler uygulanabilir; ancak bu, yaln\u0131zca kar\u015f\u0131 taraftaki kalite g\u00fcvence (QA) irtibat ki\u015fisinin s\u00f6zl\u00fc onay\u0131 ile m\u00fcmk\u00fcnd\u00fcr. S\u00f6zl\u00fc onay\u0131n ard\u0131ndan 48 saat i\u00e7inde yaz\u0131l\u0131 teyit sa\u011flanmal\u0131d\u0131r.<\/p>

5.12 Sapmalar ve \u015eik\u00e2yetler:<\/strong><\/h3>

5.12.1 S\u00f6zle\u015fme Al\u0131c\u0131s\u0131n\u0131n tesisinde meydana gelen bir sapma, bir i\u015f g\u00fcn\u00fc i\u00e7inde S\u00f6zle\u015fme Veren\u2019e bildirilir. Bildirimde, ne oldu\u011fu, hangi \u00fcr\u00fcn\u00fcn etkilendi\u011fi ve hangi \u00f6nlemlerin al\u0131nd\u0131\u011f\u0131 belirtilir.<\/p>

5.12.2 Sapma ara\u015ft\u0131rmas\u0131 ortakla\u015fa y\u00fcr\u00fct\u00fcl\u00fcr. S\u00f6zle\u015fme Al\u0131c\u0131s\u0131 teknik ara\u015ft\u0131rmay\u0131 y\u00f6netir. S\u00f6zle\u015fme Veren ise bulgular\u0131 ve CAPA plan\u0131n\u0131 inceler ve onaylar.<\/p>

5.12.3 Herhangi bir taraf\u0131n fason \u00fcretim \u00fcr\u00fcn\u00fcyle ilgili olarak ald\u0131\u011f\u0131 bir \u015fikayet, 24 saat i\u00e7inde di\u011fer tarafa bildirilir. \u015eikayet soru\u015fturmas\u0131, standart \u015fikayet i\u015fleme prosed\u00fcr\u00fcne (SOP) uygun olarak y\u00fcr\u00fct\u00fcl\u00fcr.<\/p>

5.12.4 Bir \u00fcr\u00fcn g\u00fcvenli\u011fi sorununa i\u015faret eden bir \u015fikayet, tesisin geri \u00e7a\u011f\u0131rma prosed\u00fcr\u00fcn\u00fc tetikler. Pazarlama izni kendisine ait oldu\u011fu i\u00e7in, S\u00f6zle\u015fme Veren taraf t\u00fcm piyasa \u00f6nlemlerinde \u00f6nc\u00fcl\u00fck eder.<\/p>

5.12.5 Taraflar\u0131n her biri, her bir sapma ve \u015fikayetin sonucunu di\u011fer tarafa bildirir. Rapor, her bir \u00fcr\u00fcn i\u00e7in S\u00f6zle\u015fme Kalite Dosyas\u0131\u2019na kaydedilir.<\/p>

5.13 Periyodik G\u00f6zden Ge\u00e7irme ve Denetimler:<\/strong><\/h3>

5.13.1 S\u00f6zle\u015fme Veren, S\u00f6zle\u015fme Kabul Edenin tesisini en az iki y\u0131lda bir denetler. Herhangi bir \u00f6nemli sapma veya mevzuata ili\u015fkin bulgu sonras\u0131nda, daha k\u0131sa bir s\u00fcre \u00f6ncesinde hedefli bir denetim talep edilebilir.<\/p>

5.13.2 Denetim bulgular\u0131 \u201ckritik\u201d, \u201c\u00f6nemli\u201d veya \u201c\u00f6nemsiz\u201d olarak s\u0131n\u0131fland\u0131r\u0131l\u0131r. S\u00f6zle\u015fme Al\u0131c\u0131s\u0131, denetim raporunun yay\u0131nlanmas\u0131ndan itibaren 30 g\u00fcn i\u00e7inde bir CAPA plan\u0131 sunarak yan\u0131t verir.<\/p>

5.13.3 Her s\u00f6zle\u015fme \u00fcr\u00fcn\u00fc i\u00e7in 12 ayda bir \u00dcr\u00fcn Kalite \u0130ncelemesi haz\u0131rlan\u0131r. Bu inceleme, parti verimlerini, sapmalar\u0131, \u015fikayetleri, stabilite verilerini ve de\u011fi\u015fiklik ge\u00e7mi\u015fini kapsar.<\/p>

5.13.4 \u00dcr\u00fcn Kalite \u0130nceleme Raporu her iki taraf aras\u0131nda payla\u015f\u0131l\u0131r ve her iki taraf\u0131n Kalite Sorumlusu taraf\u0131ndan imzalan\u0131r. Herhangi bir olumsuz e\u011filim, bir sonraki ortak kalite toplant\u0131s\u0131n\u0131n g\u00fcndemine al\u0131n\u0131r.<\/p>

5.13.5 Taraflar aras\u0131nda her \u00e7eyrekte en az bir kez ortak bir kalite toplant\u0131s\u0131 d\u00fczenlenir. Toplant\u0131y\u0131 S\u00f6zle\u015fmeli \u00dcretim Sorumlusu d\u00fczenler ve tutanaklar\u0131 tutar. Toplant\u0131da, hen\u00fcz \u00e7\u00f6z\u00fclmemi\u015f sapmalar, hen\u00fcz tamamlanmam\u0131\u015f CAPA\u2019lar ve yakla\u015fan de\u011fi\u015fiklikler ele al\u0131n\u0131r.<\/p>

5.14 S\u00f6zle\u015fmenin Feshi:<\/strong><\/h3>

5.14.1 Bir fason \u00fcretim anla\u015fmas\u0131, \u00e7e\u015fitli nedenlerden biri nedeniyle sona erer. Anla\u015fman\u0131n normal s\u00fcresinin dolmas\u0131, kar\u015f\u0131l\u0131kl\u0131 mutabakat, \u00fcr\u00fcn\u00fcn \u00fcretimden kald\u0131r\u0131lmas\u0131, GMP stat\u00fcs\u00fcn\u00fcn kaybedilmesi veya Kalite Anla\u015fmas\u0131\u2019n\u0131n ciddi \u015fekilde ihlali, bu t\u00fcr durumlara yol a\u00e7an tipik nedenlerdir.<\/p>

5.14.2 M\u00fcmk\u00fcn oldu\u011fu durumlarda, fiili biti\u015f tarihinden en az 180 g\u00fcn \u00f6nce bir sonland\u0131rma plan\u0131 haz\u0131rlan\u0131r. Bu plan, son parti \u00fcretimleri, numune saklama, belge ar\u015fivleme ve malzeme imhas\u0131n\u0131 kapsar.<\/p>

5.14.3 S\u00f6zle\u015fme Verene ait t\u00fcm malzemeler, fesih plan\u0131ndaki talimatlara uygun olarak iade edilir veya imha edilir. Geri g\u00f6nderilen her sevkiyat i\u00e7in bir Malzeme \u0130ade Kayd\u0131 d\u00fczenlenir.<\/p>

5.14.4 Saklanan numuneler ve parti belgeleri, s\u00f6zle\u015fme sona erdikten sonra bile t\u00fcm saklama s\u00fcresi boyunca S\u00f6zle\u015fme Kabul Eden taraf\u0131nda kal\u0131r. Bu, ticari ili\u015fkiden ba\u011f\u0131ms\u0131z olarak GMP kurallar\u0131 gere\u011fidir.<\/p>

5.14.5 Her iki taraf\u0131n Kalite Sorumlusu (QP), t\u00fcm a\u00e7\u0131k konular\u0131n kapat\u0131ld\u0131\u011f\u0131n\u0131 ve dosyan\u0131n uzun vadeli ar\u015fivlemeye haz\u0131r oldu\u011funu teyit etmek \u00fczere nihai onay verir. Bu onay, S\u00f6zle\u015fme Kalite Dosyas\u0131\u2019na eklenir.<\/p>

5.15 KAYITLAR:<\/strong><\/h3>

5.15.1 Kalite Anla\u015fmas\u0131.<\/p>

5.15.2 Tedarik\u00e7i Denetim Raporu.<\/p>

5.15.3 Teknoloji Transferi Protokol\u00fc.<\/p>

5.15.4 Teknoloji Transferi Raporu.<\/p>

5.15.5 S\u00fcr\u00fcm Karar G\u00fcnl\u00fc\u011f\u00fc.<\/p>

5.15.6 De\u011fi\u015fiklik Kontrol Talebi.<\/p>

5.15.7 S\u00f6zle\u015fme Kalite Dosyas\u0131.<\/p>

5.15.8 \u00dcr\u00fcn Kalitesi \u0130ncelemesi.<\/p>

5.15.9 Malzeme \u0130ade Kayd\u0131.<\/p>

6.0 KISALTMALAR:<\/strong><\/h2>

6.1 Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP):<\/strong> Standart \u0130\u015fletme Prosed\u00fcr\u00fc.<\/p>

6.2 Kalite G\u00fcvencesi:<\/strong> Kalite G\u00fcvencesi.<\/p>

6.3 QP:<\/strong> Yetkili Ki\u015fi.<\/p>

6.4 GMP:<\/strong> \u0130yi \u00dcretim Uygulamalar\u0131.<\/p>

6.5 CAPA:<\/strong> D\u00fczeltici \u00d6nlemler ve \u00d6nleyici \u00d6nlemler.<\/p>

6.6 PIP:<\/strong> Tesis \u0130\u00e7indeki Ki\u015fi.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Standard operating procedure of Contract Manufacturing in the Pharmaceutical Industry. 1.0 OBJECTIVE: To set out how contract manufacturing work is […]<\/p>\n","protected":false},"author":1,"featured_media":17315,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[61],"tags":[],"class_list":["post-17310","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-technology"],"acf":[],"_links":{"self":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/17310","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/comments?post=17310"}],"version-history":[{"count":0,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/17310\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/17315"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=17310"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=17310"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=17310"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}