ISPE Baseline guide volumn 7 Risk-Based Manufacture of Pharmaceutical products PDF
182 Pages·2017·7.2672 MB·other
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Preview ISPE Baseline guide volumn 7 Risk-Based Manufacture of Pharmaceutical products
Description:
The ISPE Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Second Edition provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, for managing the risk of cross-contamination within shared facilities. Risk management processes should be used to determine and document reasonable and acceptable risk, in order to maintain product quality and operator safety and to satisfy regulatory requirements.
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