SOP-QA-044.01纠正与预防措施.pdfVIP

上 海 合 全 药 业 有 限 公 司 Shanghai SynTheAll Pharmaceutical Co., Ltd SOP 编号： 标准操作程序 页码Page: 1 of 9 SOP No.: STANDARD OPERATING PROCEDURE SOP-QA-044.01 名称 Title 生效日Effective Date: Corrective Action and Preventive Action 替代 Superseded No.: SOP-QA-044.00 纠正和预防措施 起草人/ 日期 Prepared by/Date: 批准人/ 日期 Approved by/Date: QA QA 主任 Director 1. 目的PURPOSE 本程序规定合全在生产过程中产生偏差的必要行动措施。本程序描述了纠正及预防措施的要 求，目的是防止潜在问题的发生以及将来的再次发生，包括偏差、不合格或其它质量事件。 This SOP outlines the actions necessary to address deviations in manufacturing processes at STA. It describes the requirements for carrying out CAPA (corrective and preventive actions) to avoid potential problems before they arise, as well as to prevent reoccurrence of deviations, non-conformities or other quality incidents. 2. 适用范围SCOPE 纠正和预防措施涉及所有质量事件，包括偏差管理（不合格、投诉处理等质量问题）和内审、 外审等；本程序旨在描述CAPA 制定的方法以及长期CAPA 执行的评估和跟踪，具体各类质 量事件的处理CAPA，详见以下具体SOP： CAPA required for all quality events, including deviation management （non-conformity, complaint handling, etc ）and internal internal audit, etc. This SOP outlines CAPA definition as well as long term CAPA evaluation and tracking. For the detail quality issues handling, please refer to following SOPs: SOP-QA-006 《偏差管理》Deviation Management SOP-QA-020 《内部审计》Internal Audit SOP-QA-031 《外部审计管理》External Audit Management 3. 定义DEFINITIONS 纠正措施Corrective Action 消除引起现有偏差、不合格或缺陷产生的原因而采取的措施，以防止其再次发生。它包 括： An action takes to eliminate th