质量管理系统---有关CAPA系统的基本要素介绍--诺和诺德.pptVIP

* 质量管理系统 -- 有关CAPA 系统的基本要素介绍 To be printed out in 10 pcs. 涉及的主要内容 有关CAPA的相关法规 CAPA的重要性 CAPA系统的基本构成元素 总结及问答 Slide * 相关法规 preventative 3. Quality management, 3.7 Corrective and preventive actions 欧盟 EU GMP 1.4 · 8.5 Improvement, 8.5.2 Corrective action: a)—f) , 8.5.3 Preventive action: a) – e) 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 actions·taken美国药品 GMP CFR211.192 WHO GMP: Annex 4 WHO guidelines on good manufacturing practices for blood establishments management · 美of deviations国医and non-conformances,疗器械complaints, GMPevents andCFR820.100findings of (a)(1-7) (b) 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: · 中国 GMP Ch10 Sec. 6 Arti. 252-254 · 联合国卫生组织 GMP Annex 4, 3.7 · ISO9001 2008, 8.5.2, 8.5.3 Slide * · ISO 13485:2003, 8.5.2, 8.5.3 To be printed out in 10 pcs. 涉及的主要内容 有关CAPA的相关法规 CAPA的重要性 CAP