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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    P = Politeness
UserDateKCPComments
Jose02/22/17101010 
Milan01/24/17 
Milan12/15/16101010Thank you very much!
Mohamed11/19/16101010Thank you very much
Misa08/20/16101010 

Recent Answers from Michael Anisfeld

2017-02-20 Re-validation:

The trends are away from the concept of process validation being three batches.     As for re-validation most companies, except for sterile product validation, is to use annual product quality reports

2016-08-02 BFS products:

Your chances of passing an FDA (or EMA or other highly regulated country) inspection with the data you have is very close to zero. Sorry.     As I have made BFS PE containers and have been able to attain

2016-08-01 BFS products:

Dear Misa:    As you have to demonstrate a minimum of Fo = 8, I am not sure that you will have success in registering the product. with an Fo of <3. For this study you need to use pharmacopoeial recognized

2016-07-06 GMP certification:

Jose:    When FDA inspects an overseas company they can either issue a decision of "No Action Indicated" (NAI) meaning that the company has no or minor issues that will be fixed and that FDA is basically

2016-04-07 Requirement for reserve samples of APIs:

The regulations require you to keep reserve samples (equivalent to performing all testing x2). The CPGM elaborates that as well as keeping the samples, you need to visually inspect them annually(and to

 

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