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ISPE ISPE Good Practice Guide: Maintenance

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Merknad: Denne standarden har en ny utgave: ISPE ISPE Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

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Omfang

The ISPE Good Practice Guide: Maintenance provides practical solutions and tools for ensuring quality and compliance of maintenance operations in a regulated industry. Covering current and established practices, this guide helps achieve technical and regulatory accuracy and cost-effective compliance in a new or an existing maintenance program for effective strategy and efficiency. Offering maximum flexibility, this guide clearly helps define roles and responsibilities across cross-functional areas and recommends a systematic approach aimed at continuous improvement of maintenance operations. The Guide is focused on maintenance in cGMP areas and provides a practical and consistent interpretation of the necessary elements of a pharmaceutical maintenance program. The Guide seeks to enable widespread adaptation and encourage innovation.

Dokumentinformasjon

  • Standard fra ISPE
  • Publisert:
  • Utgave: 2nd
  • Versjon: 0
  • Varetype: IS
  • Products.Specs.pages

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