Does the FDA expect an assessment for effectiveness after a GMP Training?

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7/8 May 2024

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Is there an FDA requirement to perform an assessment for effectiveness after a GMP training?

Actually, the answer is no. The issue of training is covered in FDA 21 CFR 211.25. There, it reads: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions". It further stipulates that "Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them". The term "success control" is not explicitly mentioned. However, an up-to-date training level for all employees is to be maintained. Does this requirement in turn justify the requirement of an assessment for effectiveness after a training?

A recent Warning Letter issued to a South Korean pharmaceutical company helps to shed some light on the subject. Citing 21 CFR 211.25, the FDA criticises deficiencies in the training of personnel working in management, production, quality assurance and quality control. The FDA particularly points out the necessity of the training of management personnel and personnel entrusted with oversight tasks. The company's response, in which they claimed to have started an investigation due to the original Form 483 and could therefore not perform any trainings and that they would update their training matrix, was not sufficient for  the FDA. The assurance that all necessary trainings would be performed did not stop the FDA from making further demands, either.

Amongst other things, the FDA demanded that a reason why the control of the training programme was unsuccessful is to be given, and expects a detailed plan on how the effectivity of trainings is assessed.

For further details please see the FDA's Warning Letter to Samchundang Pharm Co., Ltd.