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The amount of testing is based on the supplier history and your confidence in the Supplier's Certificate of Analysis (gained by audits, comparative testing, etc.) At a minimum full specification testing
Why do you need to read pressure in warehouses? The key issue is temperature. If you are trying to keep a cephalosporin warehouse at negative pressure to the outside world, then of course you need to
Interesting questions. 21CFR211.170 on Reserve Samples states: "(b) An appropriately identified reserve sample that is representative of each lot or batch of drug product shall be retained and stored
Hi, I apologize for the lateness of my reply. I had some medical issues of my own this past week and wasn't online very much. Anyways, you are correct that there is usually a grace period. It is
Claire: You appear to be correct (but as I am not a lawyer, I cannot state that you legally "are correct"). Have you asked him to explain the rationale and logic of his actions? And ..... if your

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