§ 211.25 Personnel qualifications.
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
How BatchGlow handles this
Where a competency is defined for a step, signing is refused unless the person holds a current, unexpired qualification for it. Test results can be entered only at the testing stages the person's role is given.
What it asks for, in plain words
- 21 CFR 211.25
- Everyone who makes, processes, packs or holds a drug has the education, training and experience for the job, with continuing training in their own operations and in CGMP. Supervisors are qualified to assure the product's quality, and there are enough qualified people.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.