Two-minute brief
Good distribution practice (GDP) requirements explained: video brief
A two-minute brief on the good distribution practice requirements for medicinal products, chapter by chapter.
Key takeaways
- The EU GDP guidelines have ten chapters.
- A Responsible Person must be designated and continuously contactable.
- Suppliers and customers are qualified, and falsified medicines kept out.
- Transportation protects products and temperature to delivery.
- Competent authorities, not certification bodies, inspect GDP.
Ten chapters of the EU guidelines
The EU good distribution practice guidelines run to ten chapters; WHO's 2020 guideline covers similar ground in twenty-one sections, and national rules add detail. This short film walks through the EU chapters.
Chapter 1, quality management, asks for a documented quality system with clear management responsibilities, deviations investigated and corrective and preventive action taken, change control, control of outsourced activities, periodic management review and quality risk management, evidenced by deviation, change and CAPA logs, proportionate risk assessments and a management review with decisions. Chapter 2, personnel, requires a designated Responsible Person who carries the responsibilities personally and is continuously contactable, enough competent staff, and GDP training before and during the job. Chapter 3 covers premises and equipment, including temperature control and monitoring, and chapter 4 covers documentation.
Operations through to self-inspection
Chapter 5, operations, covers qualifying suppliers and customers, receipt, storage, destruction of obsolete goods, picking, supply, export and keeping falsified medicines out of the supply chain. Chapter 6 covers complaints, returns, suspected falsified medicinal products and recalls. Chapter 7 covers outsourced activities, chapter 8 self-inspection, chapter 9 transportation, protecting products and their temperature to the point of delivery, and chapter 10 the specific provisions for brokers. Two EU companion texts cover active substances and the safety features on packs.
GDP applies to wholesalers, importers, exporters, manufacturers distributing their own products, third-party logistics providers, carriers and freight forwarders, brokers and active substance distributors. There is no certification-body route: the competent authority grants the authorisation and inspects, and in the EU issues a GDP certificate or a statement of non-compliance.
The Responsible Person makes sure the quality system is implemented and maintained and carries duties including training, recalls, complaints, approving suppliers and customers, self-inspections and the final disposition of returned, rejected or recalled products. Temperature-sensitive products need storage mapped under representative conditions and qualified packaging, containers or vehicles in transit. Returned medicines go back to saleable stock only when every condition is met, from unopened secondary packaging to evidence of correct storage and that the product is not falsified.
GDP at a glance
- Purpose
- Medicines kept at their authorised quality from the manufacturer's dock to the pharmacy, every batch traceable and falsified supply kept out
- Relevant to
- Wholesalers, importers, exporters, manufacturers distributing their own products, 3PLs, carriers and freight forwarders, brokers, active substance distributors
- Edition
- EU GDP Guidelines 2013/C 343/01 (medicinal products) and 2015/C 95/01 (active substances); PIC/S GDP Guide PE 011-1 (June 2014); WHO good storage and distribution practices, TRS 1025, Annex 7 (2020)
- Certification
- No certification-body route. The competent authority grants the wholesale distribution authorisation and inspects; in the EU it issues a GDP certificate or a statement of non-compliance, entered in EudraGMDP
- Sterling's role
- Distribution quality system built with your team, Effivity, training, self-inspection and inspection readiness, then Sustain™
- Cost and timing
- Total investment for a GDP-compliant distribution quality system depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 3 to 9 months
GDP: questions people ask
Is there such a thing as GDP certification?
Not in the regulatory sense from a certification body. In the EU, the competent authority that inspects a wholesale distributor issues a GDP certificate, or a statement of non-compliance, and enters it in EudraGMDP; the right to trade comes from the wholesale distribution authorisation. Voluntary schemes such as IATA's CEIV Pharma sit beside that route, and a "GDP certificate" from a certification body is a voluntary audit result: possibly useful to a customer, never a substitute for the authority's decisions.
Who needs a wholesale distribution authorisation?
In the EU, anyone who procures, holds, supplies or exports medicinal products other than to the public, from the competent authority of the Member State concerned. Brokers register instead. Outside the EU the names and thresholds differ, so we confirm them against your national rules at the start.
Does GDP apply to 3PLs, transport companies and freight forwarders?
Through the distributor, always. The supplying distributor stays responsible for protecting products in transit, temperature included, and must assess and audit the warehouses and carriers it contracts. A contract acceptor needs suitable premises, equipment, procedures, knowledge and competent staff, and may not subcontract without the contract giver's approval. Whether a logistics provider also needs its own authorisation depends on its activities and on national law.
What does the Responsible Person do?
The Responsible Person makes sure a quality management system is implemented and maintained, and carries responsibilities including training, recalls, customer complaints, approving suppliers, customers and subcontracted activities, making sure self-inspections happen, and deciding the final disposition of returned, rejected, recalled or falsified products. They must be continuously contactable and may delegate duties but not responsibilities. The EU guidelines call a degree in pharmacy desirable; national law sets the qualification.
How do temperature-sensitive products change the requirements?
Storage is mapped under representative conditions before use and re-mapped when risk or significant change requires, with monitoring where the mapping found the extremes. In transit, qualified packaging, containers or vehicles are used, vehicle mapping reflects seasonal variation, and excursions are reported to the distributor and the recipient. Cold-chain returns need documented evidence that storage conditions held throughout.
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