论“返工”与“重新加工”的GMP管理

Discussion about Management for Reprocessing and Reworking Based on GMP

目的:提出对药品生产企业返工和重新加工等相关问题的处理原则和解决方案。方法:对返工和重新加工的涵义进行辨析和界定,对两者如何进行管理及其规范管理的深层次含义进行探讨。结果与结论:返工与重新加工在实际生产过程中会对产品质量产生一定的影响,必须纳入GMP,进行规范化管理。

Objective：To find basic tcncts and solutions on dealing with rcproccssing and rcworking of medicinal products. Method： To find differences bctwecn them and dcfinite them respectively, and to probe into how to rcgulatc them and what is thc interior meaning of regulating . Results and Conclution： GMP should be used to rcgulatc rcproccssing and rcworking by which the quality of medicinal products will bc affcctcd.