怎样描述再确认？

哈尔滨-HR

确认与验证管理规程细节敲定，请教怎样描述再确认？

jiangbj

再验证/Revalidation

必须定期对设施、系统、设备和工艺、包括清洗进行评估，以确认它们处在已验证的受控状态。在已验证的状态没有显著变化的条件下，一个对设施、系统、设备和工艺有满足预定要求证据的回顾性审核，即可满足再验证的要求。
Facilities, systems, equipment and processes, including cleaning, should be periodically evaluated to confirm that they remain valid. Where no significant changes have been made to the validated status, a review with evidence that facilities, systems, equipment and processes meet the prescribed requirements fulfils the need for revalidation.

在下列情况下考虑再验证/再确认：
Revalidation/ requalification shall be considered in the case of:

设备和仪器/Equipments and Instruments   
•现有的主要部件用新的部件更换   Substitution of existing major components with a new
•设备/仪器的场地/位置变更  Change of site /location of the equipment / instrument   
•现有设备/生产线购买后任何重要的修改，对最终产品的质量和有效性带来负面影响
Any major modification in the existing equipment / line since purchase which can have an adverse effect on the quality and efficacy of the finished product
•重要故障修复后（适用时）  After rectification of major breakdown (as applicable)     

生产工艺/ Manufacturing processes
•主要处方或生产工艺的变更   Change in master formula or manufacturing process   
•使用的关键工艺设备类型的变更   Change in type of critical process equipment used      
•批量的变更   Change in Batch Size   
•生产场所或位置的变更   Change in manufacturing site or location   
•作为任何产品调查的结果（如适用）As an outcome of any product investigation (if applicable)

清洗/ Cleaning   
•清洗程序和持续时间的变更   Change in cleaning cycles and durations  
•清洗剂的变更   Change in cleaning agent  
•清洗参数的变更   Change in cleaning parameters   
•生产工艺或原料供应商的变更   Change in manufacturing process or raw material or its vendor
•设备类型的变更   Change in type of equipment   
•减小批量   Reduction of batch size  

有计划的再验证/再确认/ Scheduled Revalidation / Requalification   
在项目验证计划或SOP中应确定设备、公用系统、无菌工艺、清洗方法和分析方法有计划的再验证/再确认，应规定再验证/再确认的频次。
The equipments, utility systems, aseptic processes, cleaning methods & analytical methods for scheduled revalidation / requalification shall be identified in a Project Validation Plan or SOP where frequency of revalidation / requalification shall be stated.

一般情况下，关键生产设备再验证的周期为一年。
Normally critical manufacturing equipment should be revalidated annually.

哈尔滨-HR

jiangbj 发表于 2018-8-14 09:08
再验证/Revalidation

必须定期对设施、系统、设备和工艺、包括清洗进行评估，以确认它们处在已验证的受 ...

谢谢！

晚风清凉

依据风险评估，确定是否需要在确认或验证，自己确认或验证的范围和程度