API Testing in the Focus of the Inspections of the U.S. FDA

Recommendation

Tuesday, 28 May 2024 15.30 - 17.30 h

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In May 2021, the U.S. FDA issued a Warning Letter to a Turkish over-the-counter (OTC) drug manufacturer called "Gulsah Uretim Kozmetik Sanayi Anonim Sirketi" due to significant violations of cGMP regulations for drug products.

Amongst other deficiencies listed in the FDA Warning Letter, the firm failed to verify the identity of incoming APIs (Active Pharmaceutical Ingredients) used in the finished OTC drug products. They also neglected to do a complete supplier qualification in order to demonstrate the reliability of the test results of the respective supplier. Furthermore, it is mentioned that the APIs were not adequately tested - identity and strength have not been determined - before the drug products were released for shipment. Finally, the FDA stated that the stability of the APIs used in the drug product is not shown adequately in the stability program.

For APIs, reliable tests according to approved specifications, supplier qualifications and stability testing and programs are key aspects of cGMP regulations such as the ICH Q7 guideline and need to be considered in order to maintain cGMP compliant systems in manufacturing facilities.

Coming to the final conclusion mentioned in the Warning Letter, the FDA strongly recommends engaging a cGMP consultant to support the company in aligning their systems with cGMP requirements and auditing the site to ensure the completion of the CAPA measures. The import alert, effective since March 2021, will remain in place until the Turkish manufacturer has closed all observations and fully complies with cGMP requirements, which might be checked by a further inspection.

To view the complete list of violations and the conclusion given by the FDA, please see the Warning Letter Gulsah Uretim Kozmetik Sanayi Anonim Sirketi.