C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS › Subpart B—Organization and Personnel

21 C.F.R. § 211.25

Personnel qualifications

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(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.

Notes of Decisions
Cited in 9 cases (2 in the last 5 years), 1992–2025 · leading case: Livingston v. Wyeth, Inc., 520 F.3d 344 (4th Cir. 2008).
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Livingston v. Wyeth, Inc., 520 F.3d 344 (4th Cir. 2008). · cites it 4× “21 C.F.R. § 211.25 . The regulations specify that each employee must be trained in the pertinent GMPs and in the employee's particular job functions.”
United States v. Richlyn Labs., Inc., 827 F. Supp. 1145 (E.D. Pa. 1992). “21 C.F.R. 211.25. In addition, the CGMP Regulations contemplate that drug producers and manufacturers will conduct stability testing of several batches of each of their products at regular intervals and in accordance with their written programs and that they will make and…”
United States v. Richlyn Labs., Inc., 822 F. Supp. 268 (E.D. Pa. 1993). “21 C.F.R. 211.25. In addition, the CGMP Regulations contemplate that drug producers and manufacturers will conduct stability testing of several batches of each of their products at regular intervals and in accordance with their written programs and that they will make and…”
Logan & Kanawha Coal Co. v. Banque Francaise Du Com. Exterieur, 868 F. Supp. 63 (S.D.N.Y. 1994). “§§ 3105 (e)(1)(B)(i), 3106(c); 21 C.F.R. § 211.25 (a). Second, the legislative history does not indicate any intent to create a private cause of action.”
Wright v. Fred Hutchinson Cancer Rsch. Ctr., 269 F. Supp. 2d 1286 (W.D. Wash. 2002). “116 ), manufacturers of biological and drug products ( 21 C.F.R. §§ 211.25 and 211.180, 21 C.F.R.”
United States v. Argent Chem. Labs., Inc., 93 F.3d 572 (9th Cir. 1996). “These regulations include personnel qualifications and responsibilities, 21 C.F.R. §§ 211.25 , 211.28; buildings and facilities specifications, 21 C.”
Mylan Pharm. Inc. v. United Steel, Paper & Forestry, Rubber, Mfg., Energy, Allied Indus. & Serv. Workers Int'l Union, Local 8-957, 471 F. Supp. 2d 667 (N.D.W. Va. 2007). “21 C.F.R. §§ 211.25 and 211.28 are the only regulations promulgated by the FDA that address personnel qualifications and responsibilities in relation to current GMPs for finished pharmaceuticals.”
Meridian Med. Tech., Inc. v. Int'l Bhd. of Teamsters, Local 688 (8th Cir. 2025). · cites it 2× “See 21 C.F.R. §§ 211.25 , 211.180. Meridian’s policy for proper on-the-job training is: • to assign trainers to probationary employees for OJT; • to require the trainer and trainee to complete OJT forms; • for the trainee to certify, on completion, her competence; • for the…”
Meridian Med. Tech., Inc. v. Int'l Bhd. of Teamsters, Chauffeurs, Warehousemen & Helpers of Am., Local Union No. 688 (E.D. Mo. 2024). “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.”
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