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Process Validation Food For Thought

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Feb 10 in Regulatory Compliance 0 Comments

"The old idiom says “Sticks and stones may break my bones but words will never hurt me.” Well words can hurt you."

Process Validation is defined per CFR820.75 Process validation (a) where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. Key phrase is “fully verified” - examples are sterility assurance. 


While risk-based approaches have been discussed for decades, common sense tells you that it is applied in every-day life - such as deciding whether to drive on Los Angeles freeways. So it seems harmless to apply it to Medical Processes.

Not So Fast!

In a recent FDA conference, I asked a senior FDA official whether risk-based decision is a good idea for process validation. The answer was an emphatic no! The reason was simple: QSR is the regulation that drives Process Validation; the FDA investigators must abide by QSR.

Please be cautious while applying the risk-based approach to process validations. There are ways to mitigate with written rationale.

I welcome comments/ideas/solutions.

Jack Dhuwalia, MS ChE, MBA, ASQ Certified 6 Sigma Black Belt, Manager of Quality and Auditor.

Email: Jack Dhuwalia JDC This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

About the author

Jack Dhuwalia

Jack is an expert trouble-shooter specializing in the medical industry. He has been problem-solving in R&D, manufacturing, regulatory and quality areas. Since 1992, he co-founded JD Consulting, a firm specializing in the medical industry including: devices, in vitro diagnostic devices, biologics and drugs.

Jack has expertise in design control, risk management, root cause analysis and CAPA. He teaches a graduate-level medical products life-cycle class at UCI. He is a guest lecturer at USC on quality and regulatory issues. He is a published author and has spoken on Root Cause Analysis and CAPA during FDA-OCRA events. He enjoys sharing his knowledge and public speaking.

He has served as the Membership Chair for the Orange Empire Section of ASQ and was on the executive board of OCRA, a professional organization for quality / regulatory affairs.

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