Description

This ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) provides a scientific risk-based approach based on ICH Q9 [1] to manage the risk of cross-contamination to maintain product quality and operator safety. This allows the selection of the appropriate risk control strategies to be implemented on a case by case basis to maintain an appropriate balance between assurance of product quality and worker safety.

Product Details

Edition:

2nd

Published:

07/01/2017

ISBN(s):

9781936379941

Number of Pages:

180

File Size:

1 file , 10 MB