Annual Product Review (APR) as GMP Deviation in FDA Warning Letters

Since 2002, CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation) has been analysing annually FDA's Warning Letters to drug and API manufacturers. The results have also been published on behalf of the ECA. Over this 9-year period, interesting trends have been noticed.

Reviewing FDA's Warning Letters of the last fiscal year reveals that the Annual Product Review (APR) is still a hot topic. The main reasons can be found in failing timely completion and in inadequate processes, as the following excerpts show:

• "You failed to conduct annual product reviews"
• "despite the requirements in your written procedures, […] Annual Product Reviews, your QCD has not completed annual product reviews (APRs) that include a review of approved and rejected batch records, complaints, recalls, returns, and investigations conducted on any of the products"
• "Your firm also does not describe why your APRs continued to not be completed within the timeframe established in your SOP"
• "For example, although your firm prepares annual product reviews for the products shipped to the United States, there were no written procedures describing who will prepare the reports, what information will be contained in the reports, or what the distribution of the reports should be"

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)