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目的:研究新版欧盟药品生产质量管理规范(EU-GMP)附录15草案内容,对比新旧版本中的变化,为国内制药企业能够更好地符合EU-GMP和完成确认与验证提供帮助。方法:对比新旧两版EU-GMP附录15,对新版内容变化的部分进行分析,深入理解新版附录15中的变化内容,结合国内制药企业确认与验证工作中的实施现状,对国内制药企业确认与验证工作提供建议。结果与结论:新修订EU-GMP附录15草案中强调在产品或是工艺生命周期内进行确认与验证活动以及在确认与验证活动中使用风险管理的方法。
OBJECTIVE: To study the contents of the draft Annex 15 of the new EU-GMP and to compare the changes in the old and new versions to help Chinese pharmaceutical companies better comply with EU-GMP and complete the validation and verification. Methods: Comparing the new version of EU-GMP Appendix 15 with the old and new version of Appendix 15, analyzing the changes in the content of the new version, deeply understanding the content of the changes in the new version of Appendix 15, combining with the status of implementation in the validation and verification of domestic pharmaceutical companies, Verification work to provide advice. RESULTS AND CONCLUSIONS: The newly revised EU-GMP draft Appendix 15 emphasizes the validation and validation activities during the product or process life cycle and the methods of using risk management in validation and validation activities.