ISPE ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

Jul 2017 Withdrawn

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Abstract

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.

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Standard from ISPE
Published: 1 July 2017
Edition: 2nd
Version: 0
Document type: IS
ISBN:

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ISPE ISPE Baseline Guide: Volume 7 - Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

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Abstract

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