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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 Friday, 10 February 2017
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. 

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