质量管理系统---有关CAPA系统的基本要素介绍--诺和诺德.pptVIP

Slide no * CAPA系统的构成元素 在实施行动方案之前可能需要对将要实施的行动方案进行审查和批准 投资 变更带来的风险 通过变更控制来实现 确定行动方案(CA 或PA) Slide no * CAPA系统的构成元素 CFR820.100 (a) (5) 实施并记录用来纠正和预防已发生的质量问题的方法和过程的变更; Chinese GMP 253 (5) 对实施纠正和预防措施过程中所有发生的变更应当予以记录. WHO GMP: 确保正确地记录了所采取的所有纠正措施和预防措施… 制订的行动方案应在一个合理的预先确定的时间范围内完成。 实施CA或PA Slide no * CAPA系统的构成元素 时间表 (计划), 执行人 执行情况(证据, 记录) 实施CA或PA * * * 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) –