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

Publisert

Merknad: Denne standarden har en ny utgave: ISPE ISPE Baseline Guide: Volume 8: Pharma 4.0, 1st Edition

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Omfang

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.

Dokumentinformasjon

  • Standard fra ISPE
  • Publisert:
  • Utgave: 2nd
  • Versjon: 0
  • Varetype: IS
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