CAPA系统诺和诺德解读.ppt

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 Slide no * CAPA系统的构成元素 分析/统计 /风险评估 已发生的或潜在的质量问题 执行行动方案 审核/验证/ 批准 行动方案 调查发生原因 并确定纠正或预防措施 记录并核实 有效性 信息共享和管理层审查 2012 ISPE CHINA ANNUAL CONFERENCE Hongyang Li hoyl@ 谢谢! * 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 Improvement, 8.5.2 Corrective Action: a)—f) 8.5.3 Preventive Action: a) – e) ISO13485: 8.5 Improvement, 8.5.2 Corrective action: a)—f) , 8.5.3 Preventive action: a) – e) * * To be printed out in 10 pcs. * To be printed out in 10 pcs. * * * * * To be printed out in 10 pcs. ISPE is the w