An excipient DMF is not required by law - see the The International
Pharmaceutical Excipients Council of the Americas Excipient Master
File Guide. Nor is it likely that the FDA would inspect an excipient
manufacturer [they seem to have enough trouble inspecting API
manufacturers]
However, you would be advised to check in the list of excipients used
in DMF's-this publishes those excipients used in different dosage
forms and the maximum concentrations used. As long as you are within
these parameters there should not be a problem.
That is the regulatory answer---and I believe that in spite of
efforts to introduce a DMF requirement for excipients--this will
remain the situation for a long time to come. Remember most pharma
excipients have their prime use in other areas and applying full
pharma cGMP to food additives would price them out of the market.
There is another side to the question and that is one of quality---it
is indeed your companies responsibility to have a vendor verification
program and appropriate checks in place for all materials including
excipients and packaging.
I hope this helps.
Malcolm Ross
Generapharm-Training and Consultancy
Basel-Switzerland
m.ross@generapharm.eu
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