Why Validation?
Manufacturing of finished pharmaceutical or medical devices according to GMP's (current Good Manufacturing Practices) requires validation of the manufacturing processes.
21 CFR 211.113 "Appropiate written procedures, designed to prevent microbiological contamination of druf products purporting to be sterile, shall be established and followed. Such procedures shall include validation of anysterilization process."
21 CFR 720.100 "Writtem manufacturing specifications and processing procedures shall be stablished, implemented and controlled to assure that the device conforms to its original design or any approved changes in that design."
The FDS seeks to determine wheather you have documented that your systems ans equipment "procedure a product that consistently meets or exceeds its predetermined quality attributes.
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