21 CFR Part 211.25(a)
Section 211.25 states that:
Education, Training, and Experience
(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.
Particular Operations
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.
Qualified Individuals
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.
FDA Expectation
As we can see, the FDA has an expectation that employees not only be trained and able to perform their assigned functions, but they must be trained in cGMP as it relates to these job functions. Next we’ll discuss qualifications for those supervising drug manufacturing operations.