Good distribution practice (GDP) expects everyone involved in the wholesale distribution of medicines to receive initial and continuing training that fits their role. The Responsible Person (RP) is also expected to keep their own GDP competence current through regular training. A course certificate helps to show that. It does not make anyone legally eligible to act as RP, because national law sets those qualifications.
This guide covers wholesale distribution of medicinal products for human use under the EU GDP guidelines (opens in a new tab) (2013/C 343/01). In Belgium, the same principles appear in Annex V of the Royal Decree of 14 December 2006 (opens in a new tab) (in Dutch), which uses mandatory wording. If you also distribute other product types, such as veterinary medicines or active substances, check which GDP text applies to that activity. GDP here means good distribution practice, which is a different subject from good documentation practice or the GDPR.
Who needs GDP training?
Section 2.4 of the guidelines applies to all personnel involved in wholesale distribution activities. In practice, that usually includes:
- warehouse staff who receive, store, pick and dispatch products;
- quality staff who handle deviations, complaints, returns and recalls;
- customer service and order processing, including customer qualification;
- purchasing staff who qualify suppliers;
- managers who take decisions that affect GDP.
Where you outsource storage or transport, check how the contract acceptor trains its own staff and keep that check in your supplier file. This is our recommendation for good oversight.
Staff should have the necessary competence and experience before they start their tasks. People who handle products with stricter handling conditions need specific training. The guidelines give examples: hazardous products, radioactive materials, products with a particular risk of abuse (including narcotics and psychotropic substances) and temperature-sensitive products.
What do the guidelines require?
Two sections matter most. Section 2.2 says the wholesaler must designate a Responsible Person who meets the qualifications and conditions set by the legislation of the Member State concerned. At EU level, a degree in pharmacy is described as desirable. The RP needs appropriate competence and experience, and knowledge of and training in GDP. One of the RP’s listed duties is to make sure initial and continuous training programmes are implemented and maintained.
The training section then sets out the system:
- training on GDP requirements for all personnel involved in wholesale activities;
- initial and continuing training relevant to each role, based on written procedures and a written training programme;
- regular training for the RP to maintain their GDP competence;
- content on product identification and on keeping falsified medicines out of the supply chain;
- a record of all training, with periodic assessment and documentation of its effectiveness.
In Belgium, Annex V refers to Article 95, § 2 of the Royal Decree for the RP’s qualifications and conditions. Check that article, or ask the FAMHP, before you appoint or replace an RP.
How should a Responsible Person plan refresher training?
The guidelines ask for regular training. They do not define a frequency and do not require an external course every year. That leaves room for a plan that fits your activity, as long as you can explain and document it.
We recommend reviewing the RP’s learning needs at least once a year as good practice. Trigger an extra review when something changes, for example:
- new or revised guidance from the European Commission or the FAMHP;
- inspection or self-inspection findings;
- a new product type, such as cold chain products or narcotics;
- recurring deviations, complaints or CAPA trends;
- alerts about falsified medicines.
Refresher learning can take several forms: an external course, an internal session, a structured review of new guidance, or participation in self-inspections. Record what the RP learned and why it was relevant. A short learning note works well: what changed, what the RP learned, and what was applied on site as a result. That note gives an inspector a clear line from training to practice.
What should the programme cover?
Every programme needs a shared core: GDP principles, the quality system, documentation, deviations, complaints, returns, recalls and falsified medicines. Role-specific content then builds on that core.
The matrix below is illustrative. Adapt roles, topics and methods to your own organisation.
| Role | Learning need | Topic | Assessment method | Completion record | Follow-up |
|---|---|---|---|---|---|
| Warehouse operator | Correct receipt and storage | Goods receipt, storage conditions, temperature excursions | Observed task with checklist | Signed training record and checklist | Recheck after SOP changes |
| Quality officer | Effective deviation handling | Deviations, CAPA, change control | Case exercise | Training record and exercise result | Review CAPA quality at self-inspection |
| Customer service | Supply only to authorised customers | Customer qualification, returns | Short quiz | Quiz result in training file | Spot check of new customer files |
| Purchasing | Buy only from authorised suppliers | Supplier qualification, licence checks | Review of a supplier file | Training record | Annual supplier file sample |
| Responsible Person | Maintain GDP competence | Regulatory updates, inspection trends, falsified medicines | Reflection on application to own site | Certificate or internal record, plus learning note | Yearly review of learning needs (recommended practice) |
Which records show competence?
Inspectors look for a clear link between role, training and performance. A complete file usually holds:
- the training procedure and the written training programme;
- job descriptions that define GDP responsibilities;
- a training matrix by role;
- individual records with date, content, trainer, duration and the procedure version covered;
- assessment results;
- the periodic review of training effectiveness and the actions that followed;
- proof that staff were trained on revised procedures before those procedures took effect;
- for the RP, evidence of qualifications, experience and regular GDP training.
Attendance and effectiveness are not the same thing. A signed attendance list shows that someone attended. Evidence from audits, deviations or task observation shows whether the training worked.
How to assess a course
Before you book external training, check a few points:
- Scope. Does it cover human medicines GDP under the EU guidelines and, where relevant, Belgian requirements?
- Currency. Does it reflect the current guidance and recent inspection themes?
- Trainer. Does the trainer have practical wholesale or RP experience?
- Assessment. Does the course test understanding, or only record attendance?
- Records. Does the certificate state the content, date and duration?
- Fit. Does it match the role of the person attending?
A certificate shows that someone attended or passed a course. It supports your competence file but does not establish eligibility to act as RP.
For hands-on help, our Responsible Person support covers GDP quality systems, licence work and inspection preparation. If you want a second opinion on your GDP responsibilities, discuss your situation with us.
Frequently asked questions
Is annual GDP training mandatory?
The EU guidelines require regular training for the RP and continuing training for staff, without fixing a yearly interval. A yearly review of learning needs is a sound practice. Check whether your own procedures or customer agreements set a stricter rule.
Does a certificate qualify me as an RP?
No. RP eligibility depends on the qualifications and conditions in national law. In Belgium, Annex V refers to Article 95, § 2 of the Royal Decree of 14 December 2006. A certificate is evidence of training only.
Must training match my job?
Yes. The guidelines call for initial and continuing training relevant to each person’s role, with specific training for products that need stricter handling.
What records should we keep?
Keep a record of all training, the training programme, assessment results and a periodic assessment of training effectiveness. For the RP, add evidence of qualifications and regular GDP training.
About Hendrik
Reviewed by Hendrik Staels before publication. Information as at 11 November 2026. Rules and dates can change, so check the cited sources before you act. This guide is general information, not legal advice.