GDP Quality Management System

GDP QMS — Inspection-Ready in 4 Weeks

A proven GDP quality management system, built around the EU GDP guideline and tested repeatedly during regular IGJ inspections — optionally combined with myself as your designated Responsible Person.

A wholesale distribution authorisation (WDA) stands or falls with a quality management system that demonstrably covers the requirements of the EU Good Distribution Practice (GDP) guideline (2013/C 343/01), chapter by chapter. Rather than starting from scratch, I provide an existing, fully developed GDP QMS — procedures, forms, and document control organised by GDP chapter — tailored to your organisation and processes.

Proven during IGJ inspections

This QMS is not just compliant on paper: it has already proven its value during multiple regular IGJ GDP inspections at a client, resulting in no critical or major findings and retention of the GDP certificate. Get in touch for further information and references.

Implementation in four steps

Week 1 — Intake & gap analysisMapping your current situation, activities, and licence(s) against the GDP assessment framework

Week 2 — TailoringAdapting procedures, templates, and responsibilities to your organisational structure

Week 3 — Review & trainingInternal review, approval, and GDP awareness training for the RP and relevant staff

Week 4 — Go-live & embeddingQMS effectively in use, with a follow-up plan for maintenance and periodic evaluation

Indicative timeline; the exact schedule depends on the size and complexity of your organisation.

What's included?

Full procedure set covering GDP chapters 1 through 9
Quality manual and quality policy
Templates for deviations, CAPA, change control, and self-inspections
GDP awareness training for the RP and QA staff
Implementation support from an experienced, registered RP
Optional: I act myself as the designated Responsible Person (RP) on your wholesale distribution authorisation

QMS + RP: one point of contact

For start-up wholesalers, I can combine this QMS with my own appointment as Responsible Person on your wholesale distribution authorisation — as I have done before at DocMorris N.V. and KRKA Netherlands B.V. That means you don't have to search separately for a registered RP and a working quality system: both come from the same hand, aligned from day one. As your organisation grows, I hand over the RP role in a phased manner to an internal successor, whom I train myself.