CAPA系统诺和诺德.ppt

Slide no * CAPA系统的构成元素 实施前: 是否适用 是否充分 实施后: 是否执行完毕 是否有效 (没有重复发生) 核实/验证执行结果及有效性 Slide no * CAPA系统的构成元素 有效性: 我的解决方案有用吗？ 是否引起了其他潜在的不符合项（偏差）？ 问题重复发生了吗？ 核实/验证执行结果及有效性 Slide no * CAPA系统的构成元素 CFR820.100 (a) (6) 确保有关质量问题或不合格产品的信息已通知到了那些直接对保证这些产品质量或预防此类问题发生负责的人； (7)将已发生的质量问题以及所采取的纠正和预防措施的相关信息提供给管理层审查； Chinese GMP 253 (6) 确保相关信息已传递到质量受权人和预防问题再次发生的直接负责人； (7) 确保相关信息及其纠正和预防措施已通过高层管理人员的评审； 信息分享和管理审查 Slide no * CAPA系统的构成元素 WHO GMP: 血液制品企业的管理层应对纠正和预防措施进行审查 信息分享和管理审查 Slide * 有关CAPA的相关法规 CAPA的重要性 CAPA系统的基本构成元素 涉及的主要内容 总结及问答 * To be printed out in 10 pcs. CFR211.192 Production record review: Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup EU 1.4: Product Quality Review A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken WHO GMP: Annex 4 WHO guidelines on good manufacturing practices for blood establishments 3. Quality management, 3.7 Corrective and preventive actions management of deviations and non-conformances, complaints, events and findings of the quality system management review, inspections and audits Product or quality problems should be entered into the corrective and preventive action system. Quality data include all errors, deviations, non-conformances, accidents, near-miss events and complaints. Quality data also include the results of quality control tests and monitoring activities. ISO9001: 8.5