Pharmaceuticals/Expert Profile


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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

Past/Present Clients

UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries

Something interesting about this subject that others may not know:

It is estimated that about 50% of all drugs sold on the internet are fake (counterfeit).

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    K = Knowledgeability    C = Clarity of Response    T = Timeliness    P = Politeness
UserDateKCTPComments
Alpesh10/29/0910101010 Thanks for your reply........... Thank you .....
Claire Zaiser10/27/0910101010Michael, thanks for your very prompt input .....
M Irfan10/05/0910101010thank you very much
Amanda10/01/091010 
hector09/30/091010I really appreciate the response.However,it .....

Recent Answers from Michael Anisfeld

2009-11-04 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 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 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

2009-10-27 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

2009-10-26 MAP OF DEDICATED WARE HOUSE (RAW , PACKING AND F/G ):

There is no such thing as the "ideal" warehouse, as it depends on your product needs (degree of refrigeration or cooling); and your volumes of raw materials (solids, liquids, chemicals, packaging) and

 

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