药品质量风险评估培训讲解.ppt

定义 变更控制：一个正式的系统。通过此系统，有适当专业背景的有资质的代表对提议的或实际的可能影响到设施、系统、设备或工艺验证状态的变更进行审核。目的是确定保证和记录系统维持验证状态所需采取的措施。 (WHO/PICs) 变更控制：是一项书面规程。说明了当药品生产、包装和检测中涉及到对厂房设施、原材料、设备和工艺的变更，或出现其他任何可能对产品质量或支持系统产生影响的变更时所应采取的行动和措施。(加拿大卫生部)(Health Canada) 变更管理：提出、评估、批准、执行及审核回顾变更的系统性方法。 (ICH Q10) 变更的最终批准。变更许可。 执行计划的活动事项 确定执行提议的变更所应采取的措施。 评估活动事项是否实际执行，执行后的结果及其风险是否可接受。 批准开始进行变更 定期回顾所有变更 正式系统/ 书面规程 (SOP) 描述预审系统、变更提案、为何变更 组建跨职能团队对变更的潜在效果进行审核。问问题：可能发生哪些潜在的可能影响患者安全或监管注册的问题？ 批准变更请求 确认每个潜在问题的严重性、可能性和可测性，并确认总体风险。 参考资料 PDA技术报告#44，无菌工艺质量风险管理PDA Technical Report # 44, Quality Risk Mangement for Aseptic Process PDA技术报告# 28，药品化学品无菌半成品工艺模拟测试PDA Technical Report # 28, process simulation Testing for sterile Bulk Pharmaceutical Chemicals ISPE，制药工业洁净车间设计及建设优良工程规范ISPE, Good Engineering Practices for clean room design and construction for Pharmaceutical Industry ICH Guideline – Pharmaceutical Quality System Q10. June 2008 A Risk Management Solution Designed To Facilitate Risk-Based Qualification, Validation and Change Control Activities Within GMP And Pharmaceutical Regulatory Compliance Environments In The EU. Journal of GXP Compliance, July 2006, Volume 10, Number 4 Failure Modes: Simple Strategies for Improving Qualitative Quality Risk Management Exercises during Qualification, Validation, and Change Control Activities - Journal of Validation Technology, February 2007, Volume 13, Number 2 Risk Management for Pharmaceutical Change Control. William Harclerode and Christophe Noualhac. American Pharmaceutical Review. 2007, 10 (6), 1-4. FDA Guidance for Industry - Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products – July 1997 Heath Canada Guidance Document – Post-Notice of Compliance (NOC) Changes: Quality Document. Effective Date: September 2009 Inspection of Utilities- Aide Memoire- PICS TRS 929, Annex 3 WHO Good Manufacturing Practices: water for pharmaceutical use. 参考资料 TRS 937, Annex 4 Supplementary guidelines on good manufacturing practices: v