2. Good Laboratory Practice (GLP)
2.4. Good Distribution Practice GDP
The quality and the integrity of medicinal products can be affected by a lack of adequate control of the wholesale distribution of medicinal products and active substances. Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.
Compliance with GDP ensures that:
- medicines in the supply chain are authorised in accordance with European Union (EU) legislation
- medicines are stored in the right conditions at all times, including during transportation
- contamination by or of other products is avoided
- an adequate turnover of stored medicines takes place
- the right products reach the right addressee within a satisfactory time period
The distributor should also put in place a tracing system to enable finding faulty products and an effective recall procedure.
GDP also applies to the sourcing, storage and transportation of active pharmaceutical ingredients (API) and other ingredients used in the production of the medicines.
Text from EMA: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/compliance/good-distribution-practice
Legal basis:
European Commission guidelines:
Commission guideline 2013/C 343/01 on Good Distribution Practice of medicinal products for human use based on Article 84 and Article 85b(3) of Directive 2001/83/EC
Commission guideline 2015/C 95/01 on principles of Good Distribution Practice for active substances for medicinal products for human use based on Article 47 (4) of Directive 2001/83/EC
Link to Questions and Answers document