Are your employees trained before conducting work independently?

GMP Trends Annual Report states observations pertaining to facility training programs were in the top 10 observations cited by the FDA in fiscal year 2022. Are your employees trained before conducting work independently?

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:

ā€¦.. Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.


a.         You failed to ensure employees were trained before conducting work independently and signing off on others work ā€œverifyingā€ that is was completed correctly.

i.          Employee … began employment with your company …  According to the Vice President, Quality, … can work on any activity in the manufacturing of … and its Intermediates. He also trains employees.

a).        There is no documentation of … being trained to use the …

b)         Employee … reported to be under training by Vice President, Quality and the President and CEO are documented in the batch record as having checked the work of their trainer since their first week on the job

c).        There is no documentation of … being trained on the calibration and operation of the …, … has used calibrated, operated, and reviewed the logbook for the …

d).        There is no documentation of training for sampling including but not limited to the sample method, utensils to use, etc. which is required for QC in-process samples.

ii.         Employees … and … are signing batch records such as … and … as having performed activities and the verification of activities without having completed training and there is nothing stated in the batch record stating that they are training or undergoing OJT. Steps … of … and … page 14 of 16 shows … performing the job and checking/verifying the step. Both are trainees and are supposed to be under the supervision of a trainer. The trainer did not sign off on this step.

b.         Your training procedure, SOP …, ā€œTraining Programā€, does not provide criteria for what qualifies as passing in the instance of a written test or performance evaluation. The procedure also does not define how to proceed in the case where an employee fails training.

To view more observations pertaining to training, refer to the following GMP TrendsĀ® Issues: 1119, 1118, 1114, and 1113

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