21 CFR 211.25 - Personnel Qualifications

Overview:

21 CFR 211.25 establishes personnel qualification requirements for individuals involved in manufacturing, processing, packing, or holding drug products. 

The regulation mandates that personnel have the necessary education, training, and experience to perform their tasks following current good manufacturing practices (CGMP). 

It ensures that qualified staff oversee drug production to maintain the safety, quality, and purity of the final products.

(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.