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
