略论质量风险导向的确认与验证

摘要

确认与验证、药品质量风险管理被认为是药品GMP规范的基本管理工具。 GMP规范要求确认和验证的范围和程度应经过风险评估来确定。本文研究认为，＂确认与验证＂是为了评估质量风险控制措施的效果所采取的试验、检验和检查活动，这个活动完成之后，还需要对质量风险控制措施的效果进行评估，及后续的质量风险审核、沟通过程。也就是应该在药品质量风险管理的层面上，将质量风险管理的整个流程体现到＂确认与验证＂活动之中。%PQRM( pharmaceutical Quality Risk Management ) and verification & validation , are considered to be the basic management tool drug GMP specification .The GMP specification presented that range°ree of validation&verification shall be determined by Risk Assessment .This study concluded that ,"verification&validation"is a test, examination and inspection activities are undertaken in order to assess the quality of Risk Control Measures 'effect, after the completion of this activity , also need to evaluate the effect of Risk Control Measures of Quality Risk , and quality of auditing risk , follow-up communication process .Also it should be in the Quality Risk Management of pharmaceutical , the whole process of Quality Risk Management to reflect the "verification&validation"activities.