制药企业厂房的验证

Validation of Pharmaceutical Workshops

目的为制药企业搞好生产厂房的验证工作提供参考。方法从验证的定义入手,结合《药品生产质量管理规范》(1998年版修订)第五十七条规定,探讨制药企业厂房的验证内容。结果与结论厂房验证应包括预确认、安装确认、运行确认和性能确认4个方面。

Objective It is a reference for the pharmaceutical companies to do a good job of validation of workshops. Methods Beginning with the definition of validation, combining together with the 57th regulation of 《Good Manufacturing Practice》（revised edition of 1998）, to approach the content of validation of pharmaceutical workshops. Results and Conclusions The validation of workshops should include four aspects, such as pre-qualification, installation qualification （IQ）, operational qualification （OQ） and performance qualification （PQ）.