26/27 May 2021
In a five-page warning letter to an OTC manufacturer, the FDA criticises, inter alia, the missing program for continued process verification. The FDA views the Continued Process Verification Program as important to ensure robust manufacturing processes and thereby maintain consistent product quality. It also criticised the lack of an initial validation (Process Performance Qualification).
Batch variations and QA oversight
The FDA now wants to know exactly how the company will monitor the root causes for variabilities in the future in order to minimise batch variations. It was also criticised that the company's quality assurance unit does not live up to its responsibility and authority. The FDA gathered that from the missing procedures for investigating deviations, OOS results, the handling of returned materials, the missing procedure for reprocessing and rework, missing APRs and missing rules for batch release. The FDA also didn't like that starting materials had been used based on analyses certificates from unqualified suppliers.
The FDA requirements for process validation, including the involvement of the QS unit, will be discussed with a FDA representative in a panel discussion during the ECA event Modern Qualification and Validation, which will take place on 11/12 September in Berlin.
Please also read the FDA's complete warning letter to BR SAS.