Implementation walkthrough
How to implement good distribution practice (GDP) for medicines: video walkthrough
A walkthrough of building a GDP quality system for medicines distribution and preparing for the competent authority's inspection.
Key takeaways
- GDP keeps medicines at their authorised quality from manufacturer to pharmacy.
- The competent authority authorises and inspects; there is no certification-body route.
- A designated Responsible Person is required.
- Every batch must be traceable, and falsified medicines kept out.
- Self-inspection tests the system before the authority does.
Keeping medicines at their authorised quality
Good distribution practice keeps a medicine's quality and integrity intact after it leaves the manufacturer, through every business that procures, holds, supplies or exports it on the way to the patient. Regulators set the requirements: in the European Union, the Commission's GDP guidelines for medicinal products for human use and separate guidelines for active substances; internationally, the PIC/S GDP guide and WHO's good storage and distribution practices, which extend to vaccines and medical devices.
There is 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. This short film walks through how a distributor builds the system the authority inspects.
The supplying distributor stays responsible for products in transit, temperature included, and assesses the warehouses and carriers it contracts.
From scope to inspection
Define the activities, products and sites in scope: wholesale, import, export, brokering, or storage and transport for others; ambient, refrigerated or controlled products; every site, carrier and responsible authority. A gap analysis then checks the operation against the text the regulator applies, section by section.
The quality system is built with clear management responsibilities: deviations investigated and corrective and preventive actions taken, change control, control of outsourced activities, management review and quality risk management. A designated Responsible Person carries the responsibilities personally and is continuously contactable, and staff are trained before and during the job. Premises and equipment protect products, with temperature mapping and monitoring where it matters; documentation and records make every batch traceable; operations qualify suppliers and customers and keep falsified medicines out; returns, complaints, recalls and falsified products are handled to procedure; and transportation protects the product to the point of delivery. Self-inspection then tests the system before the authority does.
Sterling's expert and experienced consultants build the distribution quality system with your team under Sterling OS™. The authority inspects and decides; no consultant or private certificate confers GDP compliance.
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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