Part 211.25 basically requires all those engaged in drug product manufacturing to have the education, training, and experience to do their jobs properly. They also need to have initial and ongoing training in CGMPs. Many companies fail in this regard and that becomes apparent during inspections when we observe employees who are not doing their job properly or do not understand and employ GMP concepts. Training has almost always been one of the top 10 reasons for getting a 483. In 2004, it was number six. [21 CFR Part 211.25 states: (A) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience…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…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…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, packing, or holding of each drug product.]
