上海cmc培訓(xùn)buildingamasterplanforpharmaceuticalcompliance-文庫吧資料
2025-01-26 01:32本頁面
【正文】 a c i l i t i e s amp。 Quality ? Definition of risk and quality – Risk may be product specific – Quality = fitness for intended use ? Science based approach to classification ? Risk identification and mitigation strategies – Major cultural change for FDA/industry ? Develop mon understanding of risk ? Borkar et al, J GXP Compliance, January 2022 *2022 AAPS Reg Challenges for Risk Based GMPs Poska CbD/CMP 062910 15 Integrated Quality System ? Link reviews and inspections – How will risk be assessed? ? Improve consistency of regulatory decisions – Between centers – Between center and field ? Product specialists on inspection teams ? Training of pharmaceutical inspectorate – Has it helped FDA embrace new technologies? *2022 AAPS Reg Challenges for Risk Based GMPs Poska CbD/CMP 062910 16 Application of “Basics” to Compliance ? Understanding systems – Technical and business processes – Risk analysis of processes – Application of DOE (ID CQA) – Application of PAT (Control CQA) ? Risk analysis – CQA controls – Inspection frequency – Defining vulnerabilities ? Trend analysis amp。 global Poska CbD/CMP 062910 7 FDA Compliance Initiatives are Multifaceted Poska CbD/CMP 062910 8 Opportunities and Threats of Globalization Ja Woodcock March 2022 ? Opportunities – Industry: cost savings, global opportunities for outsourcing ingredients – Regulators: Science based regs, collaboration with industry and other regulators, harmonized standards ? Threats – Inability to forecast vulnerabilities – Unable to foresee gaps throughout product lifecycle – Regulators amp。Poska CbD/CMP 062910 1 Compliance by Design Building a Master Plan for Pharmaceutical Compliance Global Pharmaceutical Regulatory Affairs CMC Requirements and Strategies Workshop 29 June 2022 Poska CbD/CMP 062910 2 Ultimate Risk of Nonpliance Death/AE When GMP Systems Fail ? 1999 KCl label mixup ? 2022 Albuterol Dose ? 2022, 2022 Glycerin substituted with DEG ? 2022 Viracept genotoxic contaminant ? 2022 Methotrexate/cytarabine contamination ? 2022 Heparin adulterated ? 2022 Infant formula melamine adulteration ? 2022 Tylenol contamination Poska CbD/CMP 062910 3 Presentation Goals 1. Propose concept of applying development approaches to pliance 2. Stimulate discussion on unique approach with supporting information 3. Use casestudies to explore application of concepts 4. Explore future oppo
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