cGMPs for Active Pharmaceutical Ingredient (API) and Excipient Production

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two iterations of a DRAFT guidance for industry specifically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

,https://www.khlaw.com/Files/3184_Dubeck_APO.pdf

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