RE: Vendor Qualification Of Excipient Supplier Contribution from JD Mallet written on 1/25/2012 at 23:08
Original contribution: Vendor Qualification Of Excipient Supplier written by Chirayu Mehta on 1/25/2012 at 06:51) Dear Chirayu,
Historically and still nowadays excipients used in the pharmaceutical industry were (are) also often raw materials used in the food industry.
Therefore even if not regulated like the API manufactrers are the excipient manufacturers can be more or less thought "validated for safety" via the large volumes they sell to the food industry.
Another reason is that is not so "difficult" for an API to be inefficient or even toxic (it may happen, for example, with polyporphism or impurities) while the chance for an excipient to become "toxic by accident" are low.
The risk associated to certain excipients is high when it comes to the fraudulent manufacturers (or worse : vendors) who, for exampel, will sell DEG instead of PEG ...
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