{"id":17834,"date":"2026-08-30T00:52:13","date_gmt":"2026-08-30T00:52:13","guid":{"rendered":"https:\/\/pharmamachinecn.com\/?p=17834"},"modified":"2026-05-22T07:45:51","modified_gmt":"2026-05-22T07:45:51","slug":"sop-for-product-recall-in-pharmaceutical","status":"publish","type":"post","link":"https:\/\/pharmamachinecn.com\/tr\/sop-for-product-recall-in-pharmaceutical\/","title":{"rendered":"\u0130la\u00e7 Sekt\u00f6r\u00fcnde \u00dcr\u00fcn Geri \u00c7a\u011f\u0131rma Standart \u0130\u015flem Prosed\u00fcr\u00fc (SOP)"},"content":{"rendered":"
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\u0130la\u00e7 Sekt\u00f6r\u00fcnde \u00dcr\u00fcn Geri \u00c7a\u011f\u0131rma Konusunda Standart \u00c7al\u0131\u015fma Prosed\u00fcr\u00fc.<\/p>

\"\u0130la\u00e7
\u0130la\u00e7 Sekt\u00f6r\u00fcnde \u00dcr\u00fcn Geri \u00c7a\u011f\u0131rma Standart \u0130\u015flem Prosed\u00fcr\u00fc.<\/strong><\/em><\/figcaption><\/figure>

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

Piyasaya s\u00fcr\u00fclm\u00fc\u015f ancak daha sonra kusurlu, g\u00fcvenli olmayan veya teknik \u00f6zelliklere uymayan oldu\u011fu tespit edilen herhangi bir farmas\u00f6tik \u00fcr\u00fcn\u00fcn h\u0131zl\u0131 ve etkili bir \u015fekilde geri \u00e7a\u011fr\u0131lmas\u0131na y\u00f6nelik kontroll\u00fc bir prosed\u00fcr olu\u015fturmak.<\/p>

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

Bu Prosed\u00fcr, \u00fcretim tesisinden \u00e7\u0131km\u0131\u015f olan t\u00fcm bitmi\u015f farmas\u00f6tik \u00fcr\u00fcnler i\u00e7in ge\u00e7erlidir; buna da\u011f\u0131t\u0131m zincirindeki \u00fcr\u00fcnler, toptanc\u0131larda bulunan \u00fcr\u00fcnler, eczanelerde bulunan \u00fcr\u00fcnler ve son kullan\u0131c\u0131lar elindeki \u00fcr\u00fcnler de dahildir.<\/p>

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

Geri \u00c7a\u011f\u0131rma Koordinat\u00f6r\u00fc, Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc ve Mevzuat \u0130\u015fleri Sorumlusu<\/p>

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

Genel M\u00fcd\u00fcr ve Yetkili Ki\u015fi (QP).<\/p>

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

5.1 Bir \u00fcr\u00fcn geri \u00e7a\u011f\u0131rma i\u015flemi, bir m\u00fc\u015fteri \u015fikayeti, ba\u015far\u0131s\u0131z bir stabilite sonucu, bir advers ila\u00e7 reaksiyonu raporu, bir d\u00fczenleyici kurum bulgusu veya saklanan numunede tespit edilen bir kusur nedeniyle ba\u015flat\u0131labilir.<\/p>

5.2 Olas\u0131 bir \u00fcr\u00fcn kusuruna i\u015faret eden bilgi alan herkes, bunu bir i\u015f saati i\u00e7inde Kalite G\u00fcvence M\u00fcd\u00fcr\u00fcne bildirmelidir.<\/p>

5.3 Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc, raporu al\u0131r almaz bir geri \u00e7a\u011f\u0131rma de\u011ferlendirme dosyas\u0131 a\u00e7ar. Bu dosyada \u00fcr\u00fcn ad\u0131, parti numaras\u0131, bildirilen kusur, bilgi kayna\u011f\u0131 ve rapor tarihi kaydedilir.<\/p>

5.4 Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc, de\u011ferlendirme dosyas\u0131n\u0131n a\u00e7\u0131lmas\u0131ndan itibaren d\u00f6rt saat i\u00e7inde Geri \u00c7a\u011f\u0131rma Komitesini bilgilendirir. Komite toplanana kadar kamuoyuna y\u00f6nelik herhangi bir a\u00e7\u0131klama veya distrib\u00fct\u00f6rlere y\u00f6nelik bildirim yap\u0131lmaz.<\/p>

5.4.1 Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc bu a\u015famada bir Geri \u00c7a\u011f\u0131rma Koordinat\u00f6r\u00fc de atar. Geri \u00c7a\u011f\u0131rma Koordinat\u00f6r\u00fc, geri \u00e7a\u011f\u0131rma s\u00fcrecinde g\u00fcnl\u00fck i\u015flerin y\u00fcr\u00fct\u00fclmesinden sorumlu ki\u015fidir. Koordinat\u00f6r, geri iadeleri takip eder, m\u00fc\u015fterilerle ileti\u015fim kurar ve geri \u00e7a\u011f\u0131rma s\u00fcresince departmanlar aras\u0131nda koordinasyonu sa\u011flar.<\/p>

5.5 Geri \u00c7a\u011f\u0131rma S\u0131n\u0131fland\u0131rmas\u0131:<\/strong><\/h3>

5.5.1 Her bir geri \u00e7a\u011f\u0131rma, kusurlu \u00fcr\u00fcn\u00fcn olu\u015fturdu\u011fu sa\u011fl\u0131k riski d\u00fczeyine g\u00f6re s\u0131n\u0131fland\u0131r\u0131l\u0131r. Bu s\u0131n\u0131fland\u0131rma, geri \u00e7a\u011f\u0131rma i\u015fleminin h\u0131z\u0131n\u0131 ve kapsam\u0131n\u0131 belirler.<\/p>

5.5.2 \u00dc\u00e7 geri \u00e7a\u011f\u0131rma s\u0131n\u0131f\u0131 \u015fu \u015fekilde tan\u0131mlanm\u0131\u015ft\u0131r:<\/strong><\/h4>

5.5.2.1 S\u0131n\u0131f I: \u0130lgili partinin kullan\u0131lmas\u0131 durumunda ciddi sa\u011fl\u0131k sorunlar\u0131na veya \u00f6l\u00fcme yol a\u00e7abilecek \u00fcr\u00fcnler. \u00d6rnekler aras\u0131nda yanl\u0131\u015f etken madde, y\u00fcksek riskli bir ilac\u0131n etiketinde yer alan hatalar veya toksik bir safs\u0131z\u0131n varl\u0131\u011f\u0131 say\u0131labilir.<\/p>

5.5.2.2 S\u0131n\u0131f II: Kullan\u0131m\u0131 ge\u00e7ici veya t\u0131bbi olarak geri d\u00f6n\u00fc\u015f\u00fcml\u00fc olumsuz sa\u011fl\u0131k sonu\u00e7lar\u0131na yol a\u00e7abilecek \u00fcr\u00fcnler. \u00d6rnekler aras\u0131nda etki g\u00fcc\u00fc yetersiz \u00fcr\u00fcnler, \u00e7\u00f6z\u00fcnme \u00f6zelliklerinin spesifikasyonlara uymamas\u0131 veya d\u00fc\u015f\u00fck riskli bir ilac\u0131n etiketinde yer alan k\u00fc\u00e7\u00fck hatalar say\u0131labilir.<\/p>

5.5.2.3 S\u0131n\u0131f III: Herhangi bir olumsuz sa\u011fl\u0131k sonucuna yol a\u00e7ma olas\u0131l\u0131\u011f\u0131 d\u00fc\u015f\u00fck olan, ancak kalite \u015fartnamelerine tam olarak uymayan \u00fcr\u00fcnler. \u00d6rnekler aras\u0131nda kozmetik kusurlar, ilac\u0131n kimli\u011fini etkilemeyen bask\u0131 hatalar\u0131 veya \u00f6nemsiz ambalaj kusurlar\u0131 say\u0131labilir.<\/p>

5.5.3 S\u0131n\u0131fland\u0131rma, \u00fcr\u00fcn riski, stabilite verileri ve bilinen t\u00fcm advers olay raporlar\u0131n\u0131n incelenmesinin ard\u0131ndan Geri \u00c7a\u011f\u0131rma Komitesi taraf\u0131ndan belirlenir.<\/p>

5.5.4 \u0130ki s\u0131n\u0131f aras\u0131nda s\u0131n\u0131rda kalan bir vaka, her zaman daha y\u00fcksek riskli s\u0131n\u0131fa atan\u0131r. Herhangi bir \u00fcr\u00fcn geri \u00e7a\u011f\u0131rma karar\u0131nda hasta g\u00fcvenli\u011fi, ticari etkiden daha \u00f6nceliklidir.<\/p>

5.6 G\u00f6revden Alma Komitesi:<\/strong><\/h3>

5.6.1 Geri \u00c7a\u011f\u0131rma Komitesi, Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc taraf\u0131ndan bilgilendirildikten sonra d\u00f6rt saat i\u00e7inde toplanacak \u015fekilde olu\u015fturulmu\u015f daimi bir organd\u0131r. Komite, t\u00fcm geri \u00e7a\u011f\u0131rma i\u015flemleri konusunda karar verme yetkisine sahiptir.<\/p>

5.6.2 Komite \u00fcyeleri \u015funlard\u0131r:<\/strong><\/h4>

5.6.2.1 Genel M\u00fcd\u00fcr veya ba\u015fkan olarak atanan yard\u0131mc\u0131s\u0131.<\/p>

5.6.2.2 Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc, sekreter ve kay\u0131t sorumlusu olarak.<\/p>

5.6.2.3 D\u0131\u015f ileti\u015fimden sorumlu D\u00fczenleme \u0130\u015fleri Sorumlusu.<\/p>

5.6.2.4 Parti ge\u00e7mi\u015fi ve \u00fcretim incelemesi i\u00e7in \u00dcretim Sorumlusu.<\/p>

5.6.2.5 Analitik verilerin incelenmesinden sorumlu Kalite Kontrol Sorumlusu.<\/p>

5.6.2.6 Da\u011f\u0131t\u0131m zinciri ve m\u00fc\u015fteri ili\u015fkilerinden sorumlu Ticari M\u00fcd\u00fcr.<\/p>

5.6.2.7 Sorumluluk ve s\u00f6zle\u015fme incelemesi i\u00e7in hukuk dan\u0131\u015fman\u0131.<\/p>

5.6.3 Komite ba\u015fkan\u0131, gerekti\u011finde ba\u015fka \u00fcyeleri komiteye dahil edebilir. Herhangi bir S\u0131n\u0131f I geri \u00e7a\u011f\u0131rma durumunda bir t\u0131bbi dan\u0131\u015fman komiteye eklenir.<\/p>

5.6.4 Komite kararlar\u0131, m\u00fcmk\u00fcn oldu\u011funda oy birli\u011fi ile al\u0131n\u0131r. Oy birli\u011fi sa\u011flanamazsa, ba\u015fkan her \u00fcyenin g\u00f6r\u00fc\u015f\u00fcn\u00fc dinledikten sonra nihai karar\u0131 verir.<\/p>

5.6.5 Her komite karar\u0131, Geri \u00c7a\u011f\u0131rma Karar Kay\u0131t Defteri\u2019ne kaydedilir. Her kay\u0131tta karar, haz\u0131r bulunan \u00fcyeler, varsa muhalif g\u00f6r\u00fc\u015fler ile tarih ve saat belirtilir.<\/p>

5.6.6 \u0130lk komite toplant\u0131s\u0131nda, geri \u00e7a\u011f\u0131rma s\u0131n\u0131f\u0131, geri \u00e7a\u011f\u0131rma kapsam\u0131 (tek parti mi yoksa birden fazla parti mi) ve geri \u00e7a\u011f\u0131rma derinli\u011fi (toptan sat\u0131\u015f, perakende sat\u0131\u015f veya son kullan\u0131c\u0131 d\u00fczeyi) belirlenir.<\/p>

5.6.7 Komite, aktif bir g\u00f6revden alma s\u00fcreci s\u0131ras\u0131nda haftada en az bir kez toplan\u0131r. Acil durum toplant\u0131s\u0131, ba\u015fkan veya herhangi iki \u00fcye taraf\u0131ndan her an \u00e7a\u011fr\u0131labilir.<\/p>

5.7 Yasal Bildirim:<\/p>

5.7.1 Onaylanm\u0131\u015f bir geri \u00e7a\u011f\u0131rma i\u015flemi, ilgili d\u00fczenleyici kuruma bildirilmelidir. Bildirim s\u00fcresi, geri \u00e7a\u011f\u0131rma s\u0131n\u0131f\u0131na ba\u011fl\u0131d\u0131r.<\/p>

5.7.2 Bildirim s\u00fcreleri a\u015fa\u011f\u0131daki gibidir:<\/strong><\/h4>

5.7.2.1 S\u0131n\u0131f I geri \u00e7a\u011f\u0131rma: Karar\u0131n al\u0131nmas\u0131ndan itibaren 24 saat i\u00e7inde yetkili makama bildirimde bulunulmal\u0131d\u0131r.<\/p>

5.7.2.2 S\u0131n\u0131f II geri \u00e7a\u011f\u0131rma: 72 saat i\u00e7inde bildirimde bulunulmal\u0131d\u0131r.<\/p>

5.7.2.3 S\u0131n\u0131f III geri \u00e7a\u011f\u0131rma: yedi i\u015f g\u00fcn\u00fc i\u00e7inde bildirimde bulunulmal\u0131d\u0131r.<\/p>

5.7.3 D\u00fczenleme \u0130\u015fleri Sorumlusu, onaylanm\u0131\u015f \u015fablonu kullanarak D\u00fczenleme Ama\u00e7l\u0131 Geri \u00c7a\u011f\u0131rma Bildirim Mektubunu haz\u0131rlar. Mektupta \u00fcr\u00fcn bilgileri, parti numaralar\u0131, kusur tan\u0131m\u0131, sa\u011fl\u0131k riski ve planlanan geri \u00e7a\u011f\u0131rma kapsam\u0131 yer al\u0131r.<\/p>

5.7.4 Yetkili Ki\u015fi, bildirim mektubunu g\u00f6nderilmeden \u00f6nce imzalar. \u0130mzalanm\u0131\u015f bir kopyas\u0131, Geri \u00c7a\u011f\u0131rma Ana Dosyas\u0131\u2019na dosyalan\u0131r.<\/p>

5.7.5 Yetkili makamdan gelen her t\u00fcrl\u00fc ek bilgi talebi 24 saat i\u00e7inde yan\u0131tlan\u0131r. T\u00fcm yaz\u0131\u015fmalar kay\u0131t alt\u0131na al\u0131n\u0131r ve dosyalan\u0131r.<\/p>

5.8 M\u00fc\u015fteri ve Da\u011f\u0131t\u0131c\u0131 Bildirimi:<\/strong><\/h3>

5.8.1 Ticari ekip, sevk edilen her parti i\u00e7in g\u00fcncel bir Da\u011f\u0131t\u0131m Listesi tutar. Bu liste, herhangi bir geri \u00e7a\u011f\u0131rma bildiriminin ba\u015flang\u0131\u00e7 noktas\u0131d\u0131r.<\/p>

5.8.2 Onaylanm\u0131\u015f \u015fablonu kullanarak bir geri \u00e7a\u011f\u0131rma bildirimi haz\u0131rlay\u0131n. Bildirimde \u00fcr\u00fcn ad\u0131, parti numaras\u0131, son kullanma tarihi, kusur t\u00fcr\u00fc, al\u0131c\u0131dan beklenen eylem ve geri \u00e7a\u011f\u0131rma koordinat\u00f6r\u00fcn\u00fcn ileti\u015fim bilgileri belirtilmelidir.<\/p>

5.8.3 Geri \u00c7a\u011f\u0131rma Bildirimini m\u00fcmk\u00fcn olan en h\u0131zl\u0131 yolla g\u00f6nderin. Ticari m\u00fc\u015fteriler i\u00e7in e-posta ve faks kullan\u0131l\u0131r. Kay\u0131tl\u0131 posta, yedek olarak ve resmi kay\u0131t amac\u0131yla kullan\u0131l\u0131r.<\/p>

5.8.4 Yaz\u0131l\u0131 bildirim g\u00f6nderildikten sonra her m\u00fc\u015fteriyi telefonla aray\u0131n. S\u00f6zl\u00fc ileti\u015fim, geri \u00e7a\u011f\u0131rma mesaj\u0131n\u0131n al\u0131nd\u0131\u011f\u0131n\u0131 ve anla\u015f\u0131ld\u0131\u011f\u0131n\u0131 teyit eder.<\/p>

5.8.5 Perakende d\u00fczeyindeki \u00fcr\u00fcn geri \u00e7a\u011f\u0131rma i\u015flemlerinde, sekt\u00f6r bas\u0131n\u0131yla i\u015fbirli\u011fi yaparak bir kamu duyurusu yay\u0131nlay\u0131n. Bu duyuru, d\u00fczenleyici kurum taraf\u0131ndan belirlenen s\u00fcre i\u00e7inde sekt\u00f6r dergisinde yer almal\u0131d\u0131r.<\/p>

5.8.6 Son kullan\u0131c\u0131lar\u0131 ilgilendiren S\u0131n\u0131f I geri \u00e7a\u011f\u0131rma durumunda, medya ile ileti\u015fimi tek bir onayl\u0131 s\u00f6zc\u00fc arac\u0131l\u0131\u011f\u0131yla y\u00fcr\u00fct\u00fcn. Di\u011fer personel \u00fcyelerinin gayri resmi a\u00e7\u0131klamalarda bulunmas\u0131na izin vermeyin.<\/p>

5.9 \u00dcr\u00fcn Geri Alma ve Karantina:<\/h3>

5.9.1 Depoda, geri \u00e7a\u011f\u0131rma i\u015flemleri i\u00e7in ayr\u0131lm\u0131\u015f bir karantina alan\u0131 olu\u015fturun. Bu alan, k\u0131rm\u0131z\u0131 renkli bir \u201cGER\u0130 \u00c7A\u011eIRMA\u201d etiketi ile a\u00e7\u0131k\u00e7a i\u015faretlenmeli ve kilit alt\u0131nda tutulmal\u0131d\u0131r.<\/p>

5.9.2 \u0130ade edilen \u00fcr\u00fcn, g\u00f6nderen taraf\u0131ndan doldurulmu\u015f bir \u0130ade Formu ile birlikte karantina alan\u0131na ula\u015f\u0131r. Formda g\u00f6nderenin bilgileri, parti numaras\u0131, iade edilen miktar, iade tarihi ve \u00fcr\u00fcn\u00fcn iade an\u0131ndaki durumu yer al\u0131r.<\/p>

5.9.3 Da\u011f\u0131t\u0131m Listesi\u2019ni kullanarak iade edilen miktar\u0131 da\u011f\u0131t\u0131lan miktarla kar\u015f\u0131la\u015ft\u0131r\u0131n. Geri kazan\u0131m oran\u0131n\u0131, toplam da\u011f\u0131t\u0131lan miktar\u0131n y\u00fczdesi olarak hesaplay\u0131n.<\/p>

5.9.4 Geri \u00e7a\u011fr\u0131lan \u00fcr\u00fcn\u00fc hi\u00e7bir durumda sa\u011flam stokla kar\u0131\u015ft\u0131rmay\u0131n. Karantina alan\u0131 fiziksel olarak ayr\u0131d\u0131r ve kendi envanter sistemine sahiptir. Bu alana eri\u015fim, belirlenen kalite g\u00fcvence ve depo personeli ile s\u0131n\u0131rl\u0131d\u0131r.<\/p>

5.9.5 \u0130ade edilen \u00fcr\u00fcn\u00fc, orijinal saklama \u015fartlar\u0131yla ayn\u0131 ko\u015fullarda saklay\u0131n. Geri \u00e7a\u011fr\u0131lan bir a\u015f\u0131n\u0131n, nihai imha i\u015flemine kadar so\u011fuk zincirde kalmas\u0131 gerekir. Geri \u00e7a\u011fr\u0131lan bir oral kat\u0131 ilac\u0131n ise nem ve \u0131\u015f\u0131ktan korunmas\u0131 gerekir.<\/p>

5.9.6 Kalite G\u00fcvencesi (QA), karantinaya al\u0131nmas\u0131ndan itibaren 30 g\u00fcn i\u00e7inde iade edilen \u00fcr\u00fcn\u00fcn ak\u0131betine karar verir. Se\u00e7enekler aras\u0131nda yeniden i\u015fleme (s\u0131n\u0131rl\u0131 durumlarda mevzuata uygun onay al\u0131nmas\u0131 \u015fart\u0131yla), ilave testler veya imha yer al\u0131r.<\/p>

5.9.7 Geri \u00e7a\u011fr\u0131lan \u00fcr\u00fcn\u00fcn imhas\u0131, Kalite G\u00fcvence birimi ve gerekti\u011finde bir d\u00fczenleyici kurum m\u00fcfetti\u015fi taraf\u0131ndan \u015fahitlik edilir. Her imha i\u015flemi i\u00e7in bir \u0130mha Sertifikas\u0131 d\u00fczenlenir; bu belgede imha y\u00f6ntemi, miktar, tarih ve \u015fahitlerin imzalar\u0131 yer al\u0131r.<\/p>

5.9.8 Her \u00fcr\u00fcn t\u00fcr\u00fc i\u00e7in onaylanm\u0131\u015f bir imha y\u00f6ntemi kullan\u0131n. Kat\u0131 dozaj formlar\u0131 i\u00e7in standart y\u00f6ntem yakmad\u0131r. Baz\u0131 s\u0131v\u0131lar i\u00e7in ise bertaraf \u00f6ncesinde kontroll\u00fc kimyasal i\u015flem uygulan\u0131r.<\/p>

5.10 Geri \u00c7a\u011f\u0131rma Etkinli\u011fi Kontrol\u00fc:<\/strong><\/h3>

5.10.1 Etkinlik kontrol\u00fc, geri \u00e7a\u011f\u0131rma i\u015fleminin hedef kitlesine ne \u00f6l\u00e7\u00fcde ula\u015ft\u0131\u011f\u0131n\u0131 \u00f6l\u00e7er. Kontrol, ilk Geri \u00c7a\u011f\u0131rma Bildiriminin yay\u0131nlanmas\u0131ndan itibaren 14 g\u00fcn i\u00e7inde ba\u015flat\u0131l\u0131r.<\/p>

5.10.2 Da\u011f\u0131t\u0131m Listesi\u2019ndeki m\u00fc\u015fterilerden 10%\u2019lik rastgele bir \u00f6rneklem se\u00e7in. Her biriyle ileti\u015fime ge\u00e7erek Geri \u00c7a\u011f\u0131rma Bildirimi\u2019nin al\u0131nd\u0131\u011f\u0131n\u0131 ve al\u0131nan \u00f6nlemi teyit edin.<\/p>

5.10.3 Kabul edilebilir minimum etkinlik oran\u0131, S\u0131n\u0131f I geri \u00e7a\u011f\u0131rma i\u00e7in 95%, S\u0131n\u0131f II i\u00e7in 90% ve S\u0131n\u0131f III i\u00e7in 80%\u2019dir.<\/p>

5.10.4 Etkinlik oran\u0131 s\u0131n\u0131r\u0131n alt\u0131na d\u00fc\u015ferse, geri \u00e7a\u011f\u0131rma \u00e7al\u0131\u015fmalar\u0131n\u0131 geni\u015fletin. Se\u00e7enekler aras\u0131nda ikinci bir bildirim, kilit m\u00fc\u015fterilere do\u011frudan ziyaretler veya daha geni\u015f kapsaml\u0131 bir kamuoyu bilgilendirme kampanyas\u0131 yer almaktad\u0131r.<\/p>

5.10.5 T\u00fcm etkinlik kontrol sonu\u00e7lar\u0131n\u0131 Geri \u00c7a\u011f\u0131rma Etkinlik Raporuna kaydedin. Rapor, Geri \u00c7a\u011f\u0131rma Komitesine ve talep \u00fczerine d\u00fczenleyici kuruma sunulur.<\/p>

5.11 Temel Neden ve D\u00fczeltici \u00d6nlem:<\/strong><\/h3>

5.11.1 Geri \u00e7a\u011f\u0131rma soru\u015fturmas\u0131, geri \u00e7a\u011f\u0131rma i\u015flemiyle e\u015fzamanl\u0131 olarak y\u00fcr\u00fct\u00fcl\u00fcr. Soru\u015fturma, kusurun temel nedenini ve tekrar\u0131n\u0131 \u00f6nlemek i\u00e7in al\u0131nmas\u0131 gereken d\u00fczeltici \u00f6nlemleri belirler.<\/p>

5.11.2 Soru\u015fturma ekibi, Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc taraf\u0131ndan y\u00f6netilir ve etkilenen i\u015f alanlar\u0131ndan gelen teknik uzmanlardan olu\u015fur.<\/p>

5.11.3 Bal\u0131k k\u0131l\u00e7\u0131\u011f\u0131 diyagram\u0131 veya be\u015f neden analizi gibi yap\u0131land\u0131r\u0131lm\u0131\u015f bir temel neden belirleme arac\u0131 kullan\u0131n. Se\u00e7ilen ara\u00e7, bulgularla birlikte geri \u00e7a\u011f\u0131rma dosyas\u0131n\u0131n bir par\u00e7as\u0131 olarak belgelenir.<\/p>

5.11.4 D\u00fczeltici eylemler, s\u00f6z konusu kusuru ve ilgili \u00fcr\u00fcnlerde veya partilerde bulunan benzer riskleri ortadan kald\u0131rmal\u0131d\u0131r. Bu eylemler, tesisin GMP \u00e7er\u00e7evesi kapsam\u0131nda takip edilebilmesi i\u00e7in CAPA sistemine kaydedilmelidir.<\/p>

5.11.5 Her bir d\u00fczeltici eylemin etkinli\u011fini 90 g\u00fcn sonra do\u011frulay\u0131n. Do\u011frulama i\u015fleminin ba\u015far\u0131s\u0131z olmas\u0131, yeni bir soru\u015fturma d\u00f6ng\u00fcs\u00fcn\u00fc tetikler.<\/p>

5.12 Sim\u00fclasyonlu Geri \u00c7a\u011f\u0131rma Tatbikatlar\u0131:<\/strong><\/h3>

5.12.1 Tesis, y\u0131lda en az bir kez bir geri \u00e7a\u011f\u0131rma tatbikat\u0131 d\u00fczenler. Bu tatbikat, ger\u00e7ek m\u00fc\u015fterileri dahil etmeden geri \u00e7a\u011f\u0131rma sistemini test eder.<\/p>

5.12.2 Al\u0131\u015ft\u0131rma, son 12 ayl\u0131k \u00fcretimden rastgele bir parti se\u00e7er. Ekip, Da\u011f\u0131t\u0131m Listesi arac\u0131l\u0131\u011f\u0131yla bu partinin izini son m\u00fc\u015fterilere kadar s\u00fcrer.<\/p>

5.12.3 Tatbikat\u0131n hedefi, 24 saat i\u00e7inde da\u011f\u0131t\u0131m kay\u0131tlar\u0131 arac\u0131l\u0131\u011f\u0131yla se\u00e7ilen partiden en az 95%\u2019yi tespit etmektir. Bu hedefi ger\u00e7ekle\u015ftiremeyen bir tatbikat, Da\u011f\u0131t\u0131m Listesi\u2019nde veya geri \u00e7a\u011f\u0131rma s\u00fcrecinde iyile\u015ftirmeler yap\u0131lmas\u0131n\u0131 gerektirir.<\/p>

5.12.4 Tatbikat sonu\u00e7lar\u0131n\u0131 Mock Recall Raporuna kaydedin. Eksiklikleri ve iyile\u015ftirme \u00f6nlemlerini CAPA sistemine kaydedin.<\/p>

5.13 Geri \u00c7a\u011f\u0131rma \u0130\u015fleminin Kapat\u0131lmas\u0131:<\/strong><\/h3>

5.13.1 Bir geri \u00e7a\u011f\u0131rma i\u015flemi, iade edilen t\u00fcm \u00fcr\u00fcnler kay\u0131t alt\u0131na al\u0131nd\u0131ktan ve d\u00fczeltici \u00f6nlemlerin do\u011frulanmas\u0131ndan sonra kapat\u0131l\u0131r.<\/p>

5.13.2 Olay\u0131, geri kazan\u0131m oran\u0131n\u0131, etkinlik oran\u0131n\u0131, temel nedeni ve al\u0131nan d\u00fczeltici \u00f6nlemleri \u00f6zetleyen bir Nihai Geri \u00c7a\u011f\u0131rma Raporu haz\u0131rlay\u0131n.<\/p>

5.13.3 Rapor, Kalite G\u00fcvence M\u00fcd\u00fcr\u00fc, Yetkili Ki\u015fi ve Genel M\u00fcd\u00fcr taraf\u0131ndan imzalan\u0131r.<\/p>

5.13.4 Nihai geri \u00e7a\u011f\u0131rma raporunu d\u00fczenleyici kuruma sunun. Kurum, rapordan memnun kald\u0131\u011f\u0131nda resmi bir kapan\u0131\u015f mektubu d\u00fczenler.<\/p>

5.13.5 T\u00fcm geri \u00e7a\u011f\u0131rma kay\u0131tlar\u0131n\u0131 en az be\u015f y\u0131l veya \u00fcr\u00fcn\u00fcn raf \u00f6mr\u00fc art\u0131 bir y\u0131l s\u00fcreyle saklay\u0131n; bu s\u00fcrelerden hangisi daha uzunsa o s\u00fcre boyunca saklay\u0131n.<\/p>

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

5.14.1 Geri \u00c7a\u011f\u0131rma Karar\u0131 G\u00fcnl\u00fc\u011f\u00fc.<\/p>

5.14.2 D\u00fczenleyici Kurumlara G\u00f6nderilen Geri \u00c7a\u011f\u0131rma Bildirim Mektubu.<\/p>

5.14.3 Ana Dosyay\u0131 Geri \u00c7a\u011f\u0131rma.<\/p>

5.14.4 Da\u011f\u0131t\u0131m Listesi.<\/p>

5.14.5 Geri \u00c7a\u011f\u0131rma Bildirimi.<\/p>

5.14.6 \u0130ade Formu.<\/p>

5.14.7 \u0130mha Belgesi.<\/p>

5.14.8 Geri \u00c7a\u011f\u0131rma Etkinlik Raporu.<\/p>

5.14.9 Sim\u00fclasyonlu Geri \u00c7a\u011f\u0131rma Raporu.<\/p>

5.14.10 Nihai Geri \u00c7a\u011f\u0131rma Raporu.<\/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 CAPA:<\/strong> D\u00fczeltici \u00d6nlemler ve \u00d6nleyici \u00d6nlemler.<\/p>

6.5 GMP:<\/strong> \u0130yi \u00dcretim Uygulamalar\u0131.<\/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 Product Recall in the Pharmaceutical Industry. 1.0 OBJECTIVE: To establish a controlled procedure for the prompt […]<\/p>\n","protected":false},"author":1,"featured_media":17886,"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-17834","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\/17834","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=17834"}],"version-history":[{"count":0,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/posts\/17834\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media\/17886"}],"wp:attachment":[{"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/media?parent=17834"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/categories?post=17834"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmamachinecn.com\/tr\/wp-json\/wp\/v2\/tags?post=17834"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}