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What does the FDA have to say about Validation?

The FDA has outlined the requirement that all life sciences companies validate (Good Manufacturing Practices (GMP)) systems and processes.  While the regulatory requirement is apparent, the FDA has been silent on publishing specific methodologies for achieving compliance.  The FDA allows companies to develop and justify their approach to systems validation as long as the software intended uses are properly documented and tested.

A majority of life sciences companies have chosen to utilize the International Society for Pharmaceutical Engineering (ISPE) approach detailed in their publication Good Automated Manufacturing Practices 5 (GAMP 5) as the foundation for their validation efforts.  The FDA has endorsed this risk-based methodology as an acceptable approach as well. GAMP 5 focuses attention on patient safety, product quality and data integrity for managing risk processes in the supply chain.

GAMP 5 has a top-down approach, considering that the risk associated within a system cannot be greater than the risk involved with the processes it supports.  The risk process includes:

Step 1: Perform initial risk assessment to determine system impact 

Step 2: Identify functions with impact on patient safety, product quality and data integrity

Step 3: Perform functional risk assessments and identify controls 

Step 4: Implement and verify appropriate controls

Step 5: Review risks and monitor controls  

These five steps provide a high level, yet comprehensive evaluation of risk based on the complexity of software.  While GAMP 5 scrutinizes these steps in many levels, the results of that methodology typically drive the content of the following validation documents:

  • Validation Plan
  • User Requirements/Functional Specifications
  • Traceability Matrix
  • Application Protocols
  • Validation Summary

In sum, while the requirements for systems validation is made clear by the FDA, they have not published a particular methodology required to follow.  GAMP 5 has become an approach that has been endorsed by the FDA and has become a commonly referenced standard throughout the life sciences industry.

Posted By: Joe Brundage, Validation Analyst