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.
"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.
To learn more about USDM and how we can assist with your compliance and business objectives, please contact:
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
"Simplify, Unify and Optimize your business & compliance needs with USDM"
