GMP Training How Much and How Often?

Recently in a Linkedin Group a question was asked concerning the required minimum annual GMP topics and training need to be delivered to GMP critical employees.

Training is a requirement of GMPs and this is specified in 21 CFR 211.25. Paraphrased 21 CFR 211.25 subpart (a) states that that employees should receive training including GMP training as necessary for their job functions and that this training is conducted by a qualified individual on a continuing basis with sufficient frequency to ensure employees remain familiar with the GMPs.

Thus, it is up to the organization to establish the learning curriculum for each job function, including the GMP requirements and identify the frequency that this training should be provided. So in essence, the answer to this question is “it depends”. However, that really does not help our customer when they ask how much and how often do I need to train my people! Additionally, this is not a new question, as these questions were raised and addressed by the FDA in the March 28, 1979 Preamble to the GMPs item 107 which states:

Many comments questioned the frequency of the “continuing training” required in 211.25(a), asked for a definition of the word “continuing,” and questioned who should receive what type of training.
The requirement that training be on a continuing basis is intended to mean, for example, that a single training course at the time an employee is hired, with no subsequent training activities, is not sufficient. Subsequent training should be sufficiently frequent to assure that employees remain familiar with CGMP requirements. The Commissioner does not believe it would be prudent to specify time intervals for training in view of the broad nature of the drug industry and the wide range of employee functions covered by these regulations. The Commissioner believes this section is sufficiently clear in identifying “who should receive what training” in stating that each person engaged in the manufacture, processing, packing or holding of a drug product must have training in current good manufacturing practice that relates to that person’s functions in the firm. The requirements of 211.25(a) apply to supervisors as well as other employees; 211.25(b) contains an additional requirement for supervisory personnel.

Clearly one and done training does not meet with regulatory approval and the organization should know “best” what is required to operate in compliance with the GMPs. Therefore, if I put on my ASQ Certified Quality Auditor hat my recommendation to a customer posing this question would be as follows:

  • Do you have a training curriculum for each job function; and have you specified the frequency that this training must be repeated?
  • Then I would ask to look at the CAPAs, deviations, batch and lab records, and internal audit files to ascertain if the training is adequate.

Lack of understanding, retraining, or lack of training is one of the most common corrective actions identified in FDA warning letters. This would indicate that either the training or frequency of retraining was not adequate.