21 CFR 211.25: Personnel qualifications
Requires drug manufacturers to ensure personnel and supervisors have the education, training, and experience for their roles, receive ongoing CGMP training from qualified individuals, and that enough qualified staff are available.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart B, Organization and Personnel
10%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.25, from the 483s we hold.
Employees are not given training in the particular operations they perform as part of their function.Most used
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.211.25(a)
Cited over time
483s citing 211.25, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.25
- RC Outsourcing, LLC · Lowellville, OhioEmployees are not given training in the particular operations they perform as part… Sep 3, 2026
- Dr. J Skinclinic, Inc · Cerritos, CaliforniaEmployees are not given training in the particular operations they perform as part… Mar 23, 2026
- Isorx Cyclotron Center · Lubbock, TexasYou lack personnel with the necessary training and experience to perform their… Mar 13, 2026
- Eugia Pharma Specialities Limited · Sangareddy, IndiaEmployees are not given training in the particular operatic is they perform as part… Feb 6, 2026
- Anesis Life, LLC · Macomb, MichiganFailure to ensure training is regularly conducted by qualified individuals and… Jan 29, 2026
The regulation text
§ 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.
Questions
What does 21 CFR 211.25 require?
Requires drug manufacturers to ensure personnel and supervisors have the education, training, and experience for their roles, receive ongoing CGMP training from qualified individuals, and that enough qualified staff are available.
How often is 211.25 cited in Form 483s?
It appears in about 10% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.25 observation?
The most common opening is: “Employees are not given training in the particular operations they perform as part of their function.”
Which sections are cited alongside 211.25?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.192 (Production record review), 211.160 (General requirements), 211.67 (Equipment cleaning and maintenance).