Health/Biotech

Recent Answers

2009-11-04 Pharmaceuticals - Raw material testing:

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

2009-10-30 Pharmaceuticals - Required pressure on manometers:

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

2009-10-28 Pharmaceuticals - Retain Samples:

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

2009-10-28 Health Plan Administration - Lapse in coverage ?:

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

2009-10-27 Pharmaceuticals - Off-label prescriptions:

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