PDA Survey: 2014 PDA Process Validation Survey (single user digital version)

Dec 2014
PDA Item Number

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This benchmarking survey was designed to solicit feedback on and industry status on the application of the principles established in the FDA Process Validation Guidance for Industry of 2011. The survey also investigated how companies are implementing the new lifecycle approach to process validation and any challenges encountered.

The survey team distributed the survey to the PDA membership, to the members of the Process Validation Interest Group, and to colleagues throughout the pharmaceutical and other consumer product industries.

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Format: PDF (1 file 440 KB)

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Table of Contents

Table of Contents:

  • Introduction
  • Survey Structure
  • Summary
  • Opportunities
  • General Demographics
  • General Process Validation Practices
  • Process Validation Specifics
  • Continued Process Verification (CPV)
  • Regulatory Authority Interaction