Are your employees properly trained?

Employee training for pharmaceutical GMP

Employee training is a vital part of any robust quality management plan.  GMP Trends Annual Report states observations pertaining to facility training programs were in the top 10 observations cited by the FDA in fiscal year 2021.

According to the Code of Federal Regulations (21 CFR 211.25(a) Personnel qualifications and 21 CFR 820.25(b) Personnel,

  • Personnel shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions
  • Personnel are trained to adequately perform their assigned responsibilities
  • Training shall be conducted by qualified individuals
  • Training shall be conducted on a continuing basis
  • Training shall be documented.

A company recently received the following observation:

…. Employees are not given training in the particular operations they perform as part of their function and current good manufacturing practices.


a.         President/Owner and Senior Vice President of QA/QC, who are routinely involved in the review of analytical data and issuance of Certificate of Analysis were not provided with cGMP training.

b.         The QC analyst who is involved in testing routine samples was repeatedly testing samples after analysis was completed. This testing was not documented in the lab notebook and the analyst could not explain or recall his memory why the sample was re-injected. The employee is deficient in cGMP practices.

To enhance your employee training program, visit FDA’s Training and Education program.  They have Guidance Webinars where you can ask questions on draft guidance documents under development.  The have CDERLearn and CDRHLearn where you can take online courses pertaining to drug products and medical devices.  They also have a continuing education program featuring FDA experts, focused on the safe use of drugs and medical products.

To view more observations pertaining to training, refer to the following GMP Trends® Issues: 1099, 1098, 1097, and 1096

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