Product Quality Review 产品质量回顾.docx

Product Quality Review 产品质量回顾1.4 ? ? ?Regular periodic or rolling quality reviews of all licensed 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. Such reviews should normally be conducted and documented annually, taking into account previous reviews, and should include at least: 定期对所有批准的医药产品包括出口产品进行质量回顾，进行回顾的目标是确认原辅料和成品现有工艺的稳定性，现有质量标准的适用性，强调趋势，产品鉴别和工艺优化。应进行年度的质量回顾并记录，结合先前的回顾，至少包括以下几点：(i) ? ? ?A review of starting materials including packaging materials used in the product, especially those from new sources. 该产品所用到的所有原辅料和包装材料的回顾，特别是来源于新供应商。(ii) ? ? ?A review of critical in-process controls and finished product results. 关键中控检测和成品检测结果的回顾。(iii) ? ? ?A review of all batches that failed to meet established specification(s) and their investigation. 所有不符合规定批次及其调查的回顾。(iv) ? ? ?A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken. 所有重大偏差或不符合事件及其调查，已采取的纠正和预防性措施的效果的回顾。(v) ? ? ?A review of all changes carried out to the processes or analytical methods. 所有已进行的工艺或分析方法变更的回顾。(vi) ? ? ?A review of Marketing Authorization variations submitted/granted/refused, including those for third country (export only) dossiers. 已提交/批准/拒绝的上市许可变更的回顾，包括向第三国（仅用于出口）递交的上市许可。(vii) ? ? ?A review of the results of the stability monitoring programme and any adverse trends. 稳定性实验结果和任何不良趋势的回顾。(viii) ? ? ?A review of all quality-related returns, complaints and recalls and the investigations performed at the time.所有质量相关的退货、投诉和召回，以及当时进行的调查的回顾。(ix) ? ? ?A review of adequacy of any other previous product process or equipment corrective actions. 以前对产品工艺或设备整改是否适当的回顾。(x) ? ? ?For new marketing authorizations and variations to marketing authori