1What GDP is.
WHO defines good distribution practices as the part of quality assurance that maintains a medical product’s quality “by means of adequate control of the numerous activities that occur during the trade and distribution process”, and as a tool to protect the distribution system from falsified, stolen, substandard and otherwise illegitimate products.¹ EMA describes GDP as “the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain”.²
GMP governs how a medicine is made and controlled; GDP governs how it is procured, held, supplied and exported. The two overlap: the EU guidelines say a manufacturing authorisation includes authorisation to distribute the products it covers, so “Manufacturers performing any distribution activities with their own products must therefore comply with GDP.”³
2Who must comply in the EU.
The current EU text is the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), based on Articles 84 and 85b(3) of Directive 2001/83/EC. They replaced the 1994 guidelines and a March 2013 version, and applied from the day after publication in the Official Journal on 23 November 2013.³ They are guidelines, but they carry legal weight: Article 80(g) of the Directive requires distributors to comply with the principles of and guidelines for GDP.³
Wholesale distribution means “all activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public”, and anyone doing it must hold a wholesale distribution authorisation.³ The national competent authority grants the authorisation and inspects the distributor, and after an inspection issues a GDP certificate or a statement of non-compliance, recorded in the EudraGMDP database.² Brokers, who arrange sales without handling the product, must register and follow the guidelines’ provisions for brokers.³ Importers and distributors of active substances register with their national competent authority and comply with the principles of GDP for active substances, which have their own guidelines.²
3What the EU guidelines require.
| Chapter | What it requires |
|---|---|
| 1. Quality management | A documented quality system, change control, documented and investigated deviations, corrective and preventive action, control of outsourced activities and periodic management review. |
| 2. Personnel | A designated Responsible Person who is continuously contactable and “may delegate duties but not responsibilities”, and GDP training for all staff, including on falsified medicines. |
| 3. Premises and equipment | Segregated, secure storage; temperature mapping before use; calibrated monitoring with tested alarms; validated computerised systems. |
| 4. Documentation | Records of every transaction, made at the time, kept for at least five years. |
| 5. Operations | Qualified suppliers and customers, receipt checks, storage by first expiry, first out, and a delivery note with each supply. |
| 6. Complaints, returns, falsified products and recalls | Written procedures; strict conditions for returning stock to sale; immediate reporting of falsified products; recall arrangements evaluated at least annually. |
| 7. Outsourced activities | A written contract, with the contract acceptor audited before work starts and after changes. |
| 8. Self-inspections | A programme covering all aspects of GDP, recorded, with CAPA. |
| 9. Transportation | Storage conditions kept in transit, excursions reported and investigated, monitoring equipment calibrated at least once a year. |
| 10. Brokers | Registration, a written quality system with a recall plan, training on falsified medicines, and records of each transaction. |
The Responsible Person’s duties include ensuring suppliers and customers are approved, approving subcontracted activities that may affect GDP, deciding the final disposition of returned, rejected, recalled or falsified products, and approving any return to saleable stock.³
4Storage and transport conditions.
“It is the responsibility of the supplying wholesale distributor to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport.” It should be possible to show that medicines were not exposed to conditions that could compromise their quality, using a risk-based approach to planning transport.³ Storage areas are temperature-mapped before use, and remapped based on risk or after significant change.³ How to handle a breach is covered in temperature excursions.
5Keeping falsified medicines out.
Distributors may obtain medicines only from holders of a wholesale distribution or manufacturing authorisation, must verify that a distributor supplying them holds an authorisation and complies with GDP, and carry out due diligence on new suppliers, watching for offers of products more likely to be falsified, large offers of products usually in short supply and out-of-range prices.³ They supply only customers who hold a wholesale authorisation or are entitled to supply the public.³ Any product identified or suspected as falsified is reported immediately to the competent authority and the marketing authorisation holder, and physically segregated.³
6Outside the EU.
In the UK, MHRA says GDP “requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions”. It inspects a wholesaler when it applies for a wholesale dealer licence and then periodically based on risk assessments, and grades as critical “Any departure from good distribution practice that results in a significant risk to patients.”⁴
In the US, distribution requirements sit in several places. Manufacturers’ warehousing procedures must provide quarantine before release and storage under appropriate temperature, humidity and light, and distribution procedures must ship the oldest approved stock first and let each lot’s distribution be readily determined for a recall.⁵⁶ For wholesale distributors of prescription drugs, 21 CFR 205.50 sets minimum state licensing requirements: storage at the temperatures and conditions in the labelling or compendium, temperature and humidity records, a quarantine area, examination on receipt and before dispatch, and records kept for three years.⁷ FDA describes the Drug Supply Chain Security Act as outlining steps to achieve an interoperable, electronic way to identify and trace certain prescription drugs at the package level.⁸
WHO’s 2020 guideline on good storage and distribution practices applies to everyone in the chain, from the manufacturer’s premises to the person dispensing to a patient, including brokers, logistics providers and transport companies, and is written as general guidance that countries may adapt in national or regional guidelines.¹
7How it runs in Seal.
In Seal’s warehouse, receipts, sampling withdrawals, put-away, picks and returns are attributable movements of a handling unit, with quality status, reservations and location kept with the stock and eligibility checked again at the pick. A returned container does not automatically become available: its seals, condition, time outside controlled storage and excursion evidence are captured, and it goes back through quality assessment before it can be allocated.
For temperature-
References
- 1Good storage and distribution practices for medical products, WHO Technical Report Series No. 1025, Annex 7, WHO, 2020. https:/
/ www. who. int/ publications/ m/ item/ trs- 1025- annex- 7 (read 6 November 2026) - 2Good distribution practice, EMA. https:/
/ www. ema. europa. eu/ en/ human- regulatory- overview/ post- authorisation/ compliance- post- authorisation/ good- distribution- practice (read 6 November 2026) - 3Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01), European Commission, Official Journal C 343, 23 November 2013. https:/
/ eur- lex. europa. eu/ legal- content/ EN/ TXT/ ?uri=CELEX:52013XC1123(01) (read 6 November 2026) - 4Medicines: good manufacturing practice and good distribution practice, MHRA, GOV.UK, last updated 13 May 2024. https:/
/ www. gov. uk/ guidance/ good- manufacturing- practice- and- good- distribution- practice (read 6 November 2026) - 521 CFR 211.142, Warehousing procedures, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- H/ section- 211. 142 (read 6 November 2026) - 621 CFR 211.150, Distribution procedures, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 211/ subpart- H/ section- 211. 150 (read 6 November 2026) - 721 CFR 205.50, Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records, eCFR. https:/
/ www. ecfr. gov/ current/ title- 21/ chapter- I/ subchapter- C/ part- 205/ section- 205. 50 (read 6 November 2026) - 8Drug Supply Chain Security Act (DSCSA), FDA, content current as of 16 October 2025. https:/
/ www. fda. gov/ drugs/ drug- supply- chain- integrity/ drug- supply- chain- security- act- dscsa (read 6 November 2026)
AQuestions and answers
Is GDP the same as GMP?
No. GMP covers how medicines are manufactured and controlled; GDP covers buying, holding, supplying and exporting them afterwards. In the EU, a manufacturer that distributes its own products must also comply with GDP.
Does GDP in pharma stand for good distribution practice or good documentation practice?
Both abbreviations are used. This page is about good distribution practice, the rules for storing and moving medicines through the supply chain. Documentation is one part of it: the EU guidelines have a chapter on records, which must be made at the time and kept for at least five years.
What does a GDP Responsible Person do?
Every EU wholesale distributor must designate one. The Responsible Person makes sure the quality system works, suppliers and customers are approved, recalls and complaints are handled, and self-inspections happen, decides what happens to returned, rejected, recalled or falsified products, and approves any return to saleable stock. They can delegate duties but not responsibility, and should be continuously contactable.
Is there a GDP certificate?
Yes, from the regulator. In the EU, after inspecting a wholesale distributor the national competent authority issues a GDP certificate or a statement of non-compliance and records it in the EudraGMDP database. In the UK, MHRA issues a GDP certificate with the inspection report once it accepts the distributor’s response to any deficiencies.
Does GDP apply to active substances?
Yes. In the EU, importers and distributors of active substances must register with their national competent authority and comply with the principles of GDP for active substances, which have their own guidelines. ICH Q7 also asks agents, brokers, traders and distributors of APIs to keep complete traceability of what they distribute, including the original manufacturer’s name and address.
Does the US have GDP requirements?
Not as one guideline, but the same ground is covered. Part 211 sets warehousing and distribution procedures for manufacturers, 21 CFR Part 205 sets minimum storage, handling and record requirements for state licensing of prescription drug wholesalers, and the Drug Supply Chain Security Act sets out steps towards interoperable, electronic package-level tracing of certain prescription drugs.