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 €

Détails

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.

Informations supplémentaires

Auteur International Society for Pharmaceutical Engineering
Edité par ISPE
Type de document Guide
Thème /subgroups/36281
Edition révision n° 2
EAN ISBN 9781936379941
Nombre de pages 180
Remplace ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
Mot-clé ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)