Use of non pharma grade material

Deep78 · March 31, 2016, 12:46pm

Hi my query is regarding use of non pharma grade material. If I am unable to get a pharmacopoeial grade material or any supplier is not available is it allowed to use AR grade material? Will it be accepted?

nirala · March 31, 2016, 2:55pm

Could you clarify if this is as an API or as an excipient?
Thanks

Boomer_Chemist · March 31, 2016, 5:45pm

What are the test or criteria between the 2 grades? We need more information.

Deep78 · April 1, 2016, 3:46am

This query is regarding the excipients. Testing will be done as per the pharma monograph specs however supplier will not label or claim it as BP or EP or USP

Boomer_Chemist · April 1, 2016, 12:27pm

The supplier may be reticent due to legal risks. You can test the excipient into USP/EP specifications but you also have to be sure that it is handled in a cGMP fashion downstream (your QMS), otherwise it will be disqualified (and you would have wasted both time and money).