上海cmc培訓(xùn)buildingamasterplanforpharmaceuticalcompliance-資料下載頁
2025-01-20 01:32本頁面
【正文】 ance, Mathias Klumper, HansPeter Walther, RAJPharma, February 2022 Poska CbD/CMP 062910 29 Backup Slides Poska CbD/CMP 062910 30 cGMPs (CFR 210) “Primary Mission” Minimum cGMP practice for methods to be used in, and facilities and controls to be used for, the manufacture, processing, packing or holding of a drug to assure that such drug meets the requirements of the (FDAC) act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. Poska CbD/CMP 062910 31 Compliance by design JD Fleming ? Compliance by design focuses first on identifying goals and meeting objectives. ? Master Planning develops the mode for reaching those goals and objectives. – A conceptual design for long term development. – Serves as a guide for the evolution of a facility and the foundation upon which efficient, versatile facilities are built. JD Fleming “Developing Compliance by Design and Implementing a Master Plan”. Journal of Environmental Health, 1999 Poska CbD/CMP 062910 32 QbD ? Sept 2022 PAT Guidance – Goal of PAT framework is to design and develop well understood processes that will consistently ensure a predefined quality at the end of the manufacturing – Quality should be builtin or be by design. 1. Process Understanding (CQA) 2. Principles and Tools 3. Strategy for Implementation 4. Regulatory Approach Poska CbD/CMP 062910 33 Remendations for Auto Industry Joe Barkal, Marketing Intelligence IDC Longer term, the automotive industry must invest in means to reduce the likelihood of performance quality and safety issues, and when they do occur, facilitate faster resolution. The industry should achieve: ? Consistent product taxonomy and data collection methods ? Advanced analytics to identify patterns that should be monitored ? Design and manufacturing information and traceability data that can be shared with suppliers for effective root cause analysis ? Accurate manufacturing history to facilitate accurate recalls Poska CbD/CMP 062910 34 21 CFR 211 Categories for CbD (NonQS) Scope: minimum required cGMPs for preparation of drug products ? Organization and Personnel ? Buildings and Facilities ? Equipment ? Components and Container/closures ? Production and Process Control ? Packaging and Labeling Control ? Holding and Distribution ? Laboratory Controls ? Records and Reports ? Returns and Salvage
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