转APIC：清洁验证问答.docxVIP

转APIC：清洁验证问答CleanValidation Questions Summary list：清洁验证问题一览表：Question 1: When should a company validate/revalidate cleaning procedures? When isvalidation not required?Advice: Ref. Section 7.0 and 10.0Companies should look at each situationindividually and determine the need for validation. Section 7.0 provides abasic template, which may be used as a starting point in this evaluation. Thenecessity to revalidate cleaning procedures should be determined under changecontrol parameters – See Section 10.0.If routine verification procedures areused, these should be monitored to ensure that the procedure is in control.Companies should consider a periodic evaluation of cleaning procedures , whichare subject to variation (i.e. manual procedures etc.), as an additionalprecaution to assure that the procedures are still valid.问题：公司在什么情况下对清洁程序进行验证/再验证？什么时候不需要验证？建议：参见7.0和10.0部分。公司应单独检查每一种情形，决定是否需要验证。在7.0部分中提供了一个基本模板，可以用来开始此项的评估。是否需要对清洁程序进行再验证应在变更控制下进行评估—参见10.0部分。如果使用了日常确认程序，则需要进行检测以保证程序受控。公司应考虑对可能会有变化（即人工操作程序等）的清洁程序进行定期评估，作额外的预防措施来保证清洁程序仍然有效。Question 2: When is it appropriate to useProspective, Concurrent or RetrospectiveValidation Advice: Ref. Section 9.0Retrospective Validation of cleaning is notcondoned by regulatory Authorities Prospective Validation is the ideal methodof validation.In situations where very few runs aremanufactured in any given period and/ or a business decision has been taken torelease the next material manufactured after cleaning based on a high level oftesting of the equipment (i.e. Validation level,) concurrent release ofmaterial may take place.问题：什么时候应该使用前验证、同步验证和回顾性验证？建议：参见9.0部分.药监局不认可对清洁放啊进行回顾性验证。前验证是理想的验证方法。如果给定的时间段内只生产较少的轮次，且/或已从业务角度决定了清洁后的下一生产物料将在对设备较高水平测试（即：验证水平）后才放行，则可以在验证同时放行物料。Question 3: What level of testing is neededafter cleaning validation?Advice: Ref. Section 5.3The answer to this question depends on individualsituations. Typically, companies perform visual inspection and take rinsesamples to monitor the effectiveness of the cleaning in pre