Definition · Plain-language
Good Distribution Practice (GDP)
Good Distribution Practice (GDP) is the part of quality assurance that ensures the quality and integrity of medicines are maintained throughout the supply chain, from manufacturer to the point of dispensing.
The step most authors miss
Doing CRediT right? Don’t stop at the statement.
A CRediT statement credits you inside one paper. The recognition CRediT was built for happens when those roles are tied to you, persistently. Sign in with your ORCID — free — and claim your CRediT contributions on casrai.org, the home of the standard. They become a verified, portable part of your identity, not a line that disappears into one PDF.
Free: claim your contributions, then export a journal-ready CRediT statement, schema.org structured data, JATS XML, CSV or BibTeX — and preview your public profile. A membership publishes that profile publicly and verifies the journals you serve.
Why distribution needs its own quality system
A medicine can be manufactured perfectly yet still be ruined in transit by excess heat, freezing, contamination or delay. GDP exists because product quality must be protected after it leaves the manufacturing site. It applies to wholesalers, distributors, brokers and logistics providers, requiring them to maintain validated storage conditions, controlled transport and full traceability. In this sense GDP carries GMP’s build-quality-in philosophy through the supply chain, ensuring the integrity established in manufacture is not lost on the way to the patient.
Core GDP controls
Central GDP requirements include qualifying suppliers and customers, maintaining validated temperature-controlled storage and transport (the “cold chain” for sensitive products), documented receipt and dispatch records, and procedures for handling returns, recalls and suspected falsified products. A designated Responsible Person oversees the quality system in many jurisdictions. Robust documentation and traceability mean any batch can be located and recalled rapidly, which is essential when a quality defect or safety signal emerges after distribution.
Guarding against falsified medicines
A major driver of modern GDP is preventing falsified or substandard medicines from entering the legitimate supply chain. Distributors must verify the authenticity and licensing status of their trading partners and report suspected falsified products. In the EU, GDP works alongside the Falsified Medicines Directive and its safety features (unique identifiers and anti-tamper devices). By controlling who handles a medicine and documenting every movement, GDP makes the supply chain far harder for counterfeit products to penetrate.
Key facts
At a glance
- Definition: quality system for storage, transport and supply of medicines
- Scope: wholesalers, distributors, brokers and logistics providers
- Core controls: temperature control, traceability, qualified partners
- EU reference: Guidelines on GDP of medicinal products (2013/C 343/01)
- Key role: designated Responsible Person overseeing the quality system
- Purpose: preserve product integrity and block falsified medicines
Common misconceptions
What people often get wrong
Often heard: Once a medicine passes GMP at the factory, distribution quality is automatic.
Actually: Distribution can degrade a perfectly manufactured product through heat, freezing, contamination or delay. GDP is a distinct quality system that controls storage and transport so the integrity built in during manufacture is not lost before the patient receives it.
Often heard: GDP is only about keeping medicines cold.
Actually: Temperature control is important but only one element. GDP also covers traceability, qualification of suppliers and customers, handling of returns and recalls, documentation, and prevention of falsified medicines entering the supply chain.
Often heard: GDP applies only to the manufacturer.
Actually: GDP applies across the distribution chain — wholesalers, distributors, brokers and logistics providers all carry obligations. Many jurisdictions require a designated Responsible Person to oversee the distributor’s quality system.
Going deeper
