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How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

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This e-book shows how you can establish an effective CAPA system, which interfaces there are to other systems and what content a CAPA SOP should have.

e-book

24 Seiten

ISBN: 978-3-95807-16-5

1st edition 2015

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87,00 € netto

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Excerpt from the GMP Compliance Adviser

Inadequate CAPA procedures continue to be among the leading findings in U.S. FDA and European GMP inspections. During the implementation of a CAPA system it should be ensured that the CAPA system is understood as an important element of the pharmaceutical quality system and, consequently, that it is implemented uniformly company-wide or group-wide, as a governing system.

How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment is the ultimate guide on building and implementing an effective CAPA compliance program. The e-book shows how you can establish an effective CAPA system, which interfaces there are to other systems and what content a CAPA SOP should have.

Here’s an overview of what you’ll discover in its pages:

  • Regulatory background
  • Definitions
  • Organizational Integration
  • Documentation and tracking
  • Efficacy and sustainability
  • Efficient implementation
  • Sample SOP "CAPA System"

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