PQG专论之八：制药文件化

罗伊鲱

08 – Pharmaceutical Documentation
Provides guidance on the documentation requirements for the successful manufacture and control of medicinal products. It complements the EC GMP Guide and provides a comprehensive, logical and structured reference work for those personnel preparing documents, using documents and training staff in the use of documents. It was revised in 1995.
Defnes good documentation systems practice, with an explanation of key documentation from procedures to agreements.

tsingsea

怎么理解“文件化”这个概念呢？

小兵

这是嘛玩意？

罗伊鲱

文件化：写SOP、记录、方案、报告等等。

胜利者

谢谢