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

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"