{"id":1219,"date":"2022-10-05T12:27:40","date_gmt":"2022-10-05T12:27:40","guid":{"rendered":"http:\/\/masacare.com.tr\/?page_id=1219"},"modified":"2022-10-20T06:29:23","modified_gmt":"2022-10-20T06:29:23","slug":"process","status":"publish","type":"page","link":"http:\/\/masacare.com.tr\/tr\/process\/","title":{"rendered":"\u0130\u015flem"},"content":{"rendered":"
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\u0130\u015flem do\u011frulama<\/h2>\n <\/div>\n <\/div>\n
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1. S\u00fcre\u00e7 Tasar\u0131m\u0131: Ticari s\u00fcre\u00e7, s\u00fcre\u00e7 geli\u015ftirme faaliyetleri yoluyla kazan\u0131lan bilgilere dayal\u0131 olarak bu a\u015famada tan\u0131mlan\u0131r.<\/p>\n

2. Proses Kalifikasyonu: Bu a\u015famada proses tasar\u0131m\u0131n\u0131n tekrarlanabilir ticari \u00fcretime uygun oldu\u011fu onaylan\u0131r. Tesisin, altyap\u0131 hizmetlerinin ve ekipman\u0131n kalifikasyonu dahil.<\/p>\n

3. S\u00fcrekli S\u00fcre\u00e7 Do\u011frulamas\u0131: Bak\u0131m, s\u00fcrekli do\u011frulama ve s\u00fcre\u00e7 iyile\u015ftirme. Rutin \u00fcretim s\u00fcrecinin kontrol durumunda kald\u0131\u011f\u0131na dair s\u00fcrekli g\u00fcvence. s\u0131ras\u0131nda bilgi toplayarak ve izleyerek de\u011ferlendirilir. ticarile\u015ftirme.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

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Devam Eden \u0130\u015flem Do\u011frulamas\u0131<\/h2>\n <\/div>\n <\/div>\n
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Bir kez olu\u015fturulduktan sonra, ekipman kalifikasyon durumu \u015fu yollarla s\u00fcrd\u00fcr\u00fclmelidir:<\/p>\n

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  • Rutin izleme<\/li>\n
  • Bak\u0131m onar\u0131m<\/li>\n
  • Kalibrasyon prosed\u00fcrleri ve veriler, yeniden kalifikasyonun yap\u0131l\u0131p yap\u0131lmayaca\u011f\u0131n\u0131 belirlemek i\u00e7in periyodik olarak de\u011ferlendirilmelidir.<\/li>\n <\/ul>\n

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    S\u00fcre\u00e7 yeterlilik a\u015famalar\u0131 \u015funlar\u0131 kapsar:<\/h2>\n

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    • Tesisin tasar\u0131m\u0131 ve ekipman\u0131n kalifikasyonu<\/li>\n
    • Performans kalifikasyonu <\/li>\n
    • PPQ protokol\u00fc<\/span><\/li>\n <\/ul>\n

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      S\u00fcre\u00e7 tasar\u0131m\u0131\n
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      A\u015fama 1 \u00e7\u0131kt\u0131s\u0131:<\/p>\n

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      • Kritik proses parametreleri i\u00e7in limitlerin do\u011frulanmas\u0131\/belirlenmesi.<\/li>\n
      • Limitler\/s\u00fcre\u00e7 s\u0131n\u0131r\u0131 do\u011fruland\u0131.<\/li>\n
      • Kontrol stratejisinin olu\u015fturulmas\u0131n\u0131 sa\u011flayan s\u00fcre\u00e7 de\u011fi\u015fkeni bilgisi kazan\u0131l\u0131r. <\/span><\/li>\n <\/ul>\n

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        Process Validation 1. Process Design: The commercial process is defined during this stage based on knowledge gained through process development activities. 2. Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing. Including qualification of the facility, utilities and equipment. 3. Continued Process Verification: Maintenance, continuous verification, and […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/full-width-page.php","meta":{"footnotes":""},"class_list":["post-1219","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1219","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/comments?post=1219"}],"version-history":[{"count":4,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1219\/revisions"}],"predecessor-version":[{"id":1521,"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/pages\/1219\/revisions\/1521"}],"wp:attachment":[{"href":"http:\/\/masacare.com.tr\/tr\/wp-json\/wp\/v2\/media?parent=1219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}