21 CFR 211.25 - Personnel Qualifications

What it says

Personnel engaged in manufacturing, processing, packing or holding of drug products must have education, training and experience to perform their assigned functions, must receive training in the specific operations they perform and in current good manufacturing practice, and training must be conducted on a continuing basis with sufficient frequency.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Qualification is role-specific, not generic - training must cover both the specific operations a person performs and general cGMP principles, and completing one does not satisfy the other.
• Training is an ongoing obligation with expected periodic refreshers, not a single onboarding event that satisfies the requirement indefinitely.
• For roles involving aseptic technique specifically, qualification is expected to include demonstrated, hands-on competency assessment, not classroom training alone.

What FDA inspectors look for

• Whether personnel performing specific critical operations, such as aseptic filling, have documented, role-specific qualification records, not just general GMP training completion.
• Whether training records are current, with periodic refresher training genuinely occurring on schedule rather than lapsing.
• Whether personnel interviewed during inspection can articulate the rationale behind procedures they perform, not just recite the steps.

Related regulations