Good Distribution Practice (GDP)
Maintain the integrity, quality and traceability of medicinal products from the point of manufacture to the patient.
What is Good Distribution Practice (GDP)?
Good Distribution Practice is the part of quality assurance that ensures medicinal products are consistently stored, transported and handled under conditions described by their marketing authorisation.
In the UK, GDP is enforced by the MHRA. In the EU it is governed by Directive 2001/83/EC and the 2013/C 343/01 guidelines. Certification demonstrates compliance to regulators, marketing authorisation holders and customers.
Key Benefits
Why organisations choose Good Distribution Practice (GDP).
Regulatory Compliance
Demonstrate compliance with MHRA, EMA and equivalent national requirements.
Cold Chain Integrity
Validated cold-chain processes from 2-8 °C through to ambient and controlled-room-temperature products.
Traceability End-to-End
Batch-level traceability and documented chain of custody across the distribution network.
Customer Trust
Marketing authorisation holders and pharmacies prefer GDP-certified distribution partners.
Audit-Ready Operations
Documented procedures and training records satisfy MHRA inspections without disruption.
Recall Capability
Robust recall and quarantine processes minimise risk to patient safety and to your licence.
Who is it for?
Good Distribution Practice (GDP) fits organisations across many sectors. It is particularly relevant for:
- Wholesale dealers and pharmaceutical wholesalers
- Brokers of medicinal products
- Cold-chain logistics and third-party logistics providers
- Hospital pharmacies and clinical trial supply organisations
- Importers and exporters of medicinal products
- Veterinary pharmaceutical distributors
How the Process Works
A clear, four-stage path to certification through Certigence.
Gap Assessment
We benchmark your current operations against the EU/UK GDP guidelines and identify priority areas.
System Build
Quality management system, SOPs, qualification documents and training plans are developed with your team.
Stage 1 + Stage 2 Audit
On-site audits validate the system in operation: documentation, premises, equipment, transport.
Certification & Surveillance
Certificate issued; annual surveillance audits keep you continuously inspection-ready.
Achieve GDP Certification
Whether you are seeking your first WDA or upgrading existing operations, our auditors deliver a smooth, expert path to GDP certification.
Get Certified