Training and the FDA

The US American CGMP Rules 21 CFR 211 also contain requirements concerning training (21 CFR 211.25). An actual warning letter shows the current interpretation of this requirement by the FDA. How does the FDA interpret the chapter "Training" today?

In a warning letter to the University of Miami the FDA criticised the failure to ensure regular training of the personnel that covers, at a minimum, the particular operations that each employee performs and CGMP as they relate to the employee's functions. This training ought to be conducted by qualified individuals and be documented.

Training procedures concerning the topic "training" created a week before the initiation of the FDA inspection during which the deficiency was found are inadequate from FDA's point of view. The FDA stated that the laboratory analyses carried out by the untrained persons had already taken place prior to the generation of these working procedures. It expects a retrospective assessment of the personnel to demonstrate that they had the training and the expertise to properly perform the laboratory analyses. Furthermore, the FDA expects an assessment of the laboratory practices, procedures, methods, equipment, documentation, and competencies of the personnel. Based on this assessment the recipient of the warning letter is supposed to provide a plan to remediate the laboratory routines and to evaluate the effectiveness of the laboratory system.

Conclusion: What does the FDA currently expect from a GMP training?

  • prior to performing the particular operations 
  • regularity 
  • documentation 
  • qualified trainers 
  • (performance review)

You can find the detailed warning letter on the FDA website.

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