實施PICS GMP之藥廠應執行之相關作業.pptVIP

實施PIC/S GMP之藥廠應執行之相關作業 --- Product quality review system與持續性安定性試驗等軟體差異介紹 食品藥物管理局 呂理福科長 九十九年九月十五、二十七日 大綱 Product quality review system 品質保證系統 Product quality review Corrective and Preventive Action（ CAPA） PIC/S 與我國現行GMP軟體標準差異介紹 持續性安定性試驗 文件 自我查核 確效作業 取樣方式、供應商稽查與法定留樣 Product quality review system 品質保證系統 簡介 Quality 品質系統簡介 國際標準組織ISO 世界衛生組織ＷＨＯ 美國食品藥物管理局ＦＤＡ 歐盟EC及國際醫藥品稽查協約組織ＰＩＣ/Ｓ PIC/S中有關品質保證系統之介紹 Quality System CAPA Product Quality review 我國現行GMP 第77條 ……藥廠得由其廠內各部門選派專業資深人員組成品質保證系統，定期執行廠內各項作業運作情形之確認，包括訂立廠內執行本編之自我審查作業程序，並製作紀錄、報告備查。 ISO 9000品質系統 品質系統是在建立與維持一個書面化的品質系統做為確保產品符合規定要求的手段ISO 10013 。品質保證是『一種依計畫進行，以便對實體將能達成品質要求提供信心的作業技術與活動』（ISO 8402:1994） ISO 9000:2000提升到全面品質管理(TQM)層次，在內容上，主要依據下列八大原則作為建立的基礎： 顧客導向的組織 (Customer focused organization) 領導 (Leadership) 全員參與 (Involvement of people) 流程管理 (Process approach) 系統著手的管理 (System approach to management) 持續改善 (Continual improvement) 依事實作決策 (Factual approach to decision making) 互利的供應商關係 (Mutual beneficial supplier relationship) Quality System (FDA) This system assures overall compliance with cGMP and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g., change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.) It includes all product defect evaluations and evaluation of returned and salvage drug products. Commission Directive 2003/94/EC Pharmaceutical Quality assurance means the total sum of the organized arrangements made with the object of ensuring that medicinal products or the investigational medicinal products are the quality required for their intended use. Good Manufacturing Practice means the part of quality assurance are consistently produced and controlled in accordance with the quality standards appropriate to their intended use. Quality assurance (PIC/S GMP) Quality assurance is the sum total of the organized arrangements made with the object of ensuring that medicinal products