欧盟原料药GMP认证检查项目.docVIP

欧盟原料药GMP认证检查项目 GMP Checklist for Active Pharmaceutical Ingredients (APIs) 本GMP 认证检查项目基于法规要求和个人经验。 This GMP checklist is based on regulatory requirements and personal experiences. I. 组织和人员Organization and Personnel A．质量部门责任Responsibilities of the Quality Unit (QU) 企业应当建立独立的质量部门，质量部门应当参与所有与质量有关的活动 There should be a QU that is independent of production. QU should be involved in all quality related matters. 质量部门负责所有物料、中间体和原料药的放行和拒收，以及所有与质量相关文件的审核和批准。 QU has the responsibility to release/reject all materials, intermediates, and APIs, reviews and approves all quality related documents. 质量部门要确保关键偏差得到充分调查和处理。 QU ensures that critical deviations have been fully investigated and resolved. 质量部门审核、批准/拒收中间体和原料药的生产、包装过程，或者委托加工过程。 QU reviews and approves/rejects intermediates and APIs processed, packaged, or held under contract by another company. 质量部门应建立合适的质量体系 QU establishes appropriate quality systems. 质量部门负责审核和批准： QU is responsible for review and approval of: 原料药放行前应有完整的批生产记录和实验室控制记录； Completed batch production and lab control records prior to API release 所有标准和主生产工艺； All specifications and master production instructions 所有潜在影响原料药质量的程序（如sop） All procedures (e.g. SOPs) potentially impacting API quality 验证方案和报告 Validation protocols and reports 影响原料药质量的变更 Changes impacting API quality 质量部门应确保： QU ensures that: 质量相关的投诉已经得到调查和处理； Quality related complaints are investigated and resolved 物料已经按要求测定并报告结果； Materials are appropriately tested and results are reported 有用于关键设备的维护和校验的有效体系； Effective systems are used for maintaining and calibrating critical equipment 稳定性数据支持复验期和保存条件的制定； Stability data are created to support retest dates and storage conditions 按照经批准的计划定期进行内部审计； Internal audits are performed regularly with an approved schedule 审计缺陷和纠正措施以书面形式报告并抄送相关责任部门负责人； Audit findings and corrective actions are documented and brought to the attention of responsible management 制定年度产品质量回顾报告 Product quality reviews (pre