基于风险评估的制药用水系统验证

介绍了典型的制药用水系统的基础知识和验证流程,并举例进行了说明,重点关注了基于风险评估的制药用水系统的验证生命周期,使其更符合法规和指南的要求。

IEC 62059 Standards' Application in Reliability Prediction and Verification of Smart Meters

This article introduces the current situation of the smart then describes the relationship of meter reliability characteristics meter＇s reliability and the failure mechanisms at first, and combined with its Bathtub Curve. It also introduces both the feasible failure tree model for meter lifecycle prediction based on actual experiences and meter reliability prediction methodology by SN 29500 norms based on this model. This article also brings forward that it is necessary that the ＂Learning Factor＂ shall be adopted in meter reliability prediction for new materials, new process, and customized parts by referring to GJB/Z299C. Thereafter, this article also tries to apply IEC 62059 and JB/T 50070 to introduce the feasible method for the lifecycle prediction result verification by accelerated lifecycle test. Furthermore, the article also explores ways to increase the firmware reliability in smart meter.

现行国内外药品工艺验证指南解读

国际人用药品注册技术协调会(ICH)于2017年6月19日,正式公布原中国国家食品药品监督管理总局(CFDA)加入其成为成员国,意味着中国药品监管和药品注册技术要求与国际协调一致的紧迫性和必要性。通过对中国、美国、欧盟、世界卫生组织(WHO)等关于药品生产工艺验证指南的学习,结合经验及实例,对国内外生产工艺验证要求进行解读,确定基于风险的、生命周期工艺验证方法即现代工艺验证方法,已经得到国内外权威监管机构及制药企业的认可。