Guidance for Industry on Process Validation: General Principles and Practices

The Parenteral Drug Association (PDA) is pleased to offer comments on the FDA Draft Guidance for Industry Process Validation: General Principles and Practices. PDA is a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality. Our comments were prepared by a committee of experts with experience in process validation and were reviewed and approved by PDA Advisory Boards and Committees. PDA appreciates the opportunity to offer comments on this Draft Guidance and wishes to thank FDA for the opportunity to do so.