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CPV
Continuous Process Verification
Непрерывное подтверждение технологического процесса

 

CPV originated with the GMPs (21CFR211.110):
•“Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.”


Stage 3 of the updated FDA Validation Guidelines:
•“The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture.”

 

Continuous Process Verification
Brendan Hughes

Implementing an Operations Intelligence System to Automate a Continued Process Verification (CPV) Program at Baxter BioScience
CONTINUED PROCESS VERIFICATION MONITORING AND MAINTAINING
THE VALIDATED STATE LIFECYCLE APPROACH TO PROCESS VALIDATION – FDA STAGE 3

 

 


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