What Chapter 2 requires
All personnel involved in wholesale distribution activities should be trained on GDP requirements, and should receive initial and continuing training relevant to their role. Training should be based on written procedures and delivered according to a written programme, with records kept.
The RP is responsible for ensuring initial and continuing training programmes are implemented and maintained. That makes the training system an RP-owned area even where HR administers it.
Attendance versus competence
A record showing that a person attended a session on a date establishes that the session happened. It does not establish that they can perform the task. Inspectors increasingly probe this distinction, particularly for tasks where an error has product impact.
Competence evidence can take several forms: an assessment following the training, supervised performance signed off by a competent person, a periodic knowledge check, or a documented observation of the task. The form matters less than that some assessment exists and is recorded.
Building a training matrix
The matrix should map roles to required training, and individuals to their current status. It is most useful when it is driven by task rather than by job title, because it then reveals gaps when someone covers an unfamiliar task.
Areas that normally need role-specific training
- GDP awareness appropriate to the role.
- The specific SOPs the person operates under.
- Temperature monitoring and excursion response for storage and despatch staff.
- Bona fide checking for staff who onboard or approve counterparties.
- Falsified medicines recognition and escalation.
- Recall procedure for anyone who could receive a notification.
- Deviation raising, so that staff know the threshold is low.
- Controlled drugs handling where applicable, including safe custody and record keeping.
Keeping it current
Training needs to be retriggered by change, not only by the calendar. A revised SOP, a new piece of equipment, a change in scope or a deviation that revealed a knowledge gap should each generate training activity linked back to the cause.
Refresher frequency should be defined and justified. Where refresher training is overdue across a team, that is visible in the matrix and is a straightforward finding.
Temporary and agency staff
Agency and temporary staff performing GDP-relevant tasks require training on the same basis as permanent staff, proportionate to what they do. Because turnover is higher, this is a frequent gap. The practical control is that system access and task authorisation should not be granted before the relevant training is recorded.
Common questions
- How often is GDP refresher training required?
- No fixed period is specified. Your procedure should define the frequency and justify it, and the defined frequency should be met. Annual refresher is common for core GDP awareness.
- Do we need to train staff who never touch product?
- If their work affects GDP compliance — order processing, customer onboarding, procurement, transport arrangements — then yes, proportionate to their role.
- Does the RP need their own continuing training?
- Yes. The RP is expected to maintain current knowledge, and inspectors may ask what the RP has done to keep up to date with guidance changes.
Sources
- Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use 2013/C 343/01
- MHRA Guidance Note 6 — applicants and holders of a Wholesale Dealer’s Licence or Broker Registration Fifth edition 2022, section 9 amended 2023