EU GMP Chapter 2 - Personnel

What it says

Sufficient qualified personnel must be available to carry out all tasks for which the manufacturer is responsible, with key personnel including the Qualified Person holding defined statutory responsibilities, and all personnel receiving initial and continuing training relevant to their duties including specific training on the principles of the pharmaceutical quality system.

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

What it means in practice

• Chapter 2 defines statutory key personnel roles, most notably the Qualified Person, with legally defined responsibilities that carry personal accountability, a structural feature more explicit than the equivalent US framework's approach to personnel qualification.
• Training requirements explicitly extend to quality system principles generally, not only role-specific technical training, reflecting the broader EU GMP expectation that all personnel understand the quality system they operate within.
• This chapter connects directly to the senior management responsibilities described in Chapter 1, together establishing personnel accountability at both the individual role level and the organisational leadership level.

What inspectors look for

• Whether personnel holding statutory key roles, particularly the Qualified Person, have documented qualifications genuinely meeting the specific statutory requirements for that role.
• Whether training records demonstrate both role-specific technical competency and broader understanding of quality system principles.
• Whether personnel resourcing is genuinely sufficient for the scale and complexity of the site's operations, not stretched thin in ways that compromise quality oversight.

Related regulations