Have you conducted your annual GMP training this year?

GMP training is an important part of your company’s compliance, and helps ensure that your employees are properly trained.  According to the Code of Federal Regulations (21 CFR 211.25(a) Personnel qualifications and 21 CFR 820.25(b) Personnel,

gmp training
  • 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 engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

Specifically, the firm has deficiencies in the employee training program.

a.         There is no documentation for any GMP training that has been received by the individuals at the firm who conduct employee trainings (i.e., train-the-trainer), such as the R & D Manager, or the QC Lead, who are members of the firm’s quality control unit.

b.         Although group GMP training sessions are documented for employees last year, there is no evidence to show that prior years of employee trainings have been conducted. Moreover, approximately six (6) Corrective Actions Reports state that employees required retraining/additional training, but there is no evidence to show the completion of such trainings.

c.         On-the-job trainings, including evaluation of performance for specific job functions in warehousing, manufacturing, and the QC Laboratory, are not (always) documented. Examples include, but are not limited to operators and technicians who perform: Warehouse operations, such as raw materials and components receiving, shipping and inventory control; Bulk drug product batch compounding operations; Drug product filling operations; Drug product packaging and labeling operations; and Quality Control Laboratory analytical and/or microbiological testing methods

To view more observations pertaining to training, refer to the following GMP Trends® Issues: 1054, 1057,  1060, 1063,  1065, and 1066

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