ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Product

ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Product

International Society for Pharmaceutical Engineering, 07/01/2017

€637.00

Details

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.

Additional Info

Author International Society for Pharmaceutical Engineering
Published by ISPE
Document type Guide
Theme /subgroups/36281
Edition 2
EAN ISBN 9781936379941
Number of pages 180
Replace ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
Keyword ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)