27年度产品质量回顾.pptx

年度产品质量回顾张新Cynthia ZhangGMP合规性及质量管理咨询服务 高级咨询经理cynthiazhang@1产品年度质量回顾的目的及法规要求32产品年度质量回顾报告的主要内容产品年度质量回顾中的统计知识应用目录15产品质量回顾的目的Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements.应当对所有获得批准的药品，包括仅供出口的药品，进行定期的或滚动式的质量回顾，质量回顾的目的是确认现有工艺的一致性、起始物料和成品现行质量标准的适宜性，关注任何趋势并识别产品和工艺改进点。 EU GMP Part I - Basic Requirements for Medicinal Products 第一部分 药品基本要求 1.10节产品质量回顾的目的确认现有工艺的一致性起始物料和成品现行质量标准的适宜性关注任何趋势并识别产品和工艺改进点国外GMP对年度回顾的要求FDA1979年3月生效，21CFR211.180(e)ICH Q7a, API GMPAPR (Annual Product Review) EU2013年1月生效EU GMP 第一章 1.10节PQR (Product Quality Review) 中国GMP（2010年修订）2011年3月1日起施行EU GMP 第一章 1.10节 Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least:通常应当每年回顾并文件化，回顾中还应当考虑以前的回顾情况，并至少应当包括：(i)A review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances.回顾产品所用起始物料、包装材料，特别是来自新供应商的起始物料和包装材料，尤其是回顾原料药供应链的可追溯性。(ii)A review of critical in-process controls and finished product results.回顾关键中间控制与成品结果。(iii)A review of all batches that failed to meet established specification(s) and their investigation.回顾未能符合既定质量标准的所有批次及其调查结果。EU GMP 第一章 1.10节(iv)A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventive actions taken.回顾所有重大偏差或不符合事件与相关调查，以及后续纠正与预防措施的有效性。(v)A review of all changes carried out to the processes or analytical methods. 回顾工艺或分析方法的所有变更。(vi)A review of Marketing Authorisation variations submitted, granted or refused, including those for third country (export only) dossiers.回顾已递