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.
Document identifier
ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
ISPE Category
Baseline Guides
Publication date
2017-07-01
International Relationship
History of version
ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) * ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
| Price |
515 vnd |
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