cGMPs for Active Pharmaceutical Ingredient (API) and Excipient Production

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For many years the only Food and Drug Administration
(FDA) document specifically related to current good
manufacturing practice (cGMP) requirements for active
pharmaceutical ingredient (API) manufacturers was a guid-
ance for FDA investigators that covered all Bulk
Pharmaceutical Chemicals (BPCs). Over the past few years,
two iterations of a DRAFT guidance for industry specifically
addressing API manufacture were published. On September
25, 2001, the lack of specific, official cGMP guidance for
API manufacturers came to an end when “FDA’s Guidance
for Industry:
Q7A Good Manufacturing Practice Guidance
for Active Pharmaceutical Ingredients (“Q7A”)”
read at
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