Pharmaceutical Quality Resources

As part of an application to make a drug applicants are expected to show that they can consistently produce a quality product.  The following resources are helpful in achieving this goal, and may also be helpful for other types of products such as OTC monograph products:
In addition to our cGMP regulations, the following resources expand on FDA’s post-application expectations for manufacturers of drug substances and drug products.

Page Last Updated: 06/15/2017
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