FDA Biopharmaceutical Release, Stability and Container Closure Integrity Testing
Biopharmaceutical Company of recombinant therapeutic proteins needs FDA GMP Laboratory for Release, Stability and Container Closure Integrity testing (CCIT).
The package integrity verification will be performed on the final drug product as release and stability testing .
The biopharmaceutical drug product, is water based, supplied as a liquid in 15 ml glass vials stored at 5°C under nitrogen.
For this reason we are looking:
The test method used for CCIT should be a validated method.
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