Dear Michael: My company is buying lyophilized finished forms from a new supplier whose product's specification are much more exigent than our old supplier. When we analyzed this products before release, we are using the old supplier's specification(the product has no USP monograph. I'm not sure if what we do is correct, and if should I change my limits every time that i have a new supplier?. We have a very good history with the old supplier product.

Dear Jose:

I am not sure what you mean by the word "exigent", but my below response should be of assistance.

You have a finished product specification that you have registered with the regulatory authorities; and thus you can release the product to market if it meets these specifications.

So, question, does this "new supplier" meet your product specification - Yes or No?
If YES, then purchase, if NO, then do not purchase.

You should NOT change your registered specification every time you change a supplier.

I hope this helps.


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Michael Anisfeld


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


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