Good Distribution Practice (GDP)
If you store, move, or sell human medicines in the UK, Good Distribution Practice (GDP) is the rulebook that keeps products safe, traceable, and within the legal supply chain. GDP isn’t just an SOP set on a shelf; it’s the day-to-day system that protects product quality from procuring to holding, supplying, and exporting. And it’s a legal expectation for wholesale dealers under a WDA(H). The EU GDP Guideline (2013/C 343/01) sets the benchmark followed across the UK and Europe and is the reference inspectors use to judge whether your quality system works in real life.
What does GDP cover?
At heart, GDP is about control and continuity. The right products, in the right condition, to the right customer, with records an inspector can follow without guesswork. The guideline anchors this in a documented quality system (change control, CAPA, management review, risk management), competent personnel and training, fit-for-purpose premises and equipment, validated transport/temperature control, and outsourcing that is qualified and monitored, not left to trust. It also formalises the role of the Responsible Person (RP), who must have the authority and competence to keep the system effective and intervene when standards slip.
How this links to the MHRA and Inspections
GDP inspections in the UK are risk-based. Your activities (cold-chain, volume, complexity) and your history of deficiencies influence the cadence and depth of inspection. That’s why “paper-perfect” SOPs are not enough, inspectors trend what happens in practice, then schedule based on risk. GOV.UK
Recent MHRA conference data underline where businesses stumble most often: documentation that doesn’t match reality, weak temperature control, incomplete QMS execution, and shaky governance around outsourced activities. One MHRA symposium reviewed 1,189 GDP deficiencies across 473 inspections (Oct 2021–Nov 2022), with the top issues clustering in familiar places: Chapters 1–6 of the GDP guideline. MHRA Inspectorate+1
The RP’s place in GDP
The RP isn’t a ceremonial signature, they’re the linchpin. The guideline expects them to be continuously contactable, to fulfil responsibilities personally, and to have the authority/resources to run an effective system: training that lands, recalls coordinated promptly, suppliers/customers approved, self-inspections done and CAPA closed, and clear decisions on returns/rejects/falsified goods. In short, the RP is how GDP stays real and compliant between inspections.
If your operation also imports licensed medicines into Great Britain from an approved country, you’ll additionally need RPi responsibilities covered. The Responsible Person (Import) verifies QP certification (and certain batch certificates) for each batch before it enters the GB supply chain, distinct duties from the GDP RP, and assessed against separate guidance.
What “good GDP” looks like day-to-day
Strong GDP is pragmatic. It means your quality system explains how you control risk and your evidence proves that it works, contemporaneous records, trained people, qualified transport routes, temperature mapping and monitoring that hold up under stress, and outsourcing that’s contracted, qualified, and reviewed. When inspectors open a file, they should be able to “read your logic” from issue to decision, not hunt for missing pages.
Common pitfalls (and how to stay out of them)
Where GDP falters, it usually starts with mis-matched reality. People doing one thing while the SOP says another, or temperature excursions handled ad hoc with no scientific rationale. Another frequent gap is outsourcing without oversight; carriers, 3PLs. Where responsibilities blur and findings multiply. The fix isn’t a longer SOP, it’s a tighter loop, risk-based change control, scenario-based training, evidence-led decisions, and management reviews that trigger real actions. These are precisely the areas inspectors keep highlighting in trend data.
GDP vs GMP (and where they meet)
GMP controls the manufacture and batch certification; GDP controls distribution quality once the batch is released. Manufacturers distributing their own products still have to comply with GDP for those activities. The hand-over between GMP and GDP is a quality-critical seam: when it’s weak, recalls and complaints escalate; when it’s strong, inspections are calmer, shorter, and cleaner.
Your next best step
If your GDP system hasn’t had any internal checks in the last year, run one. Pick a real batch or complaint and follow it across your process, end-to-end. Where the trail breaks, fix the system and the training. Give your RP the time, access, and reporting line they need to lead.
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Helpful Links & Resources
EU GDP Guideline (2013/C 343/01) — the baseline for GDP expectations across the UK/EU. EUR-Lex
MHRA: Good manufacturing practice and good distribution practice — inspection approach and risk scoring. GOV.UK
MHRA GDP Symposium (2023) — deficiency trends and learning points. MHRA Inspectorate
GMP/GDP non-compliance trend overview (2023) — issues mapped to GDP Chapters 1–6. GMP Compliance
GOV.UK: Acting as a Responsible Person (Import) — when RPi applies and what it must verify. GOV.UK
