• Manufacturing Systems


Process Validation

Process validation is a requirement of the Current Good Manufacturing Practices Regulations (cGMP) for Finished Pharmaceuticals, 21 CFR Parts 210 and 211, and of the Good Manufacturing Practice Regulations for Medical Devices, 21 CFR Part 820, and therefore, is applicable to the manufacture of pharmaceuticals and medical devices.

The FDA defines process validation as follows:

"Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality characteristics."

The LAST thing a Regulated company would want to see is:

"Written procedures for production and process controls designed to assure drug product quality have not been implemented, insofar as no data could be supplied demonstrating successful process validation for a number of your products [21 CFR 21 1.100(a)]" – FDA Warning Letter.

USDM provides our partners in the Life Science Industry with industry proven validation consultants that are experienced in Process Validation.



  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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