GDP (Good Distribution Practice): Pharmaceutical

GDP (Good Distribution Practice): A set of guidelines that ensures the proper storage, transportation, and distribution of pharmaceutical products to maintain their quality and integrity.

See also:

United Kingdom:

  1. The Human Medicines Regulations 2012 (as amended) – This regulation governs the distribution, storage, and transportation of medicinal products, including the compliance with GDP for medicines.

  2. The Medicines and Healthcare Products Regulatory Agency (MHRA) – Enforces GDP requirements within the UK, ensuring pharmaceutical distribution practices comply with safety and quality standards.

  3. The Controlled Drugs (Supervision of the Supply Chain) Regulations 2007 – Regulates the distribution of controlled drugs within the UK, setting out specific GDP requirements for their transport and storage.

  4. The UK Good Distribution Practice (UK GDP) – Specifies guidelines for the storage, transportation, and distribution of medicinal products to ensure their integrity and quality are maintained.

  5. The UK Medicines Act 1968 – Provides overarching legislation for the regulation of medicines in the UK, including distribution practices.

European Union:

    1. Directive 2001/83/EC (as amended) – Establishes the EU legal framework for medicinal products, including requirements for GDP to ensure the quality and safety of medicines throughout the supply chain.

    2. GDP Guidelines (2013/C 343/01) – These European guidelines set out the standards for the proper distribution of medicinal products for human use, covering aspects such as storage, transport, and handling in the supply chain.

    3. Regulation (EC) No 1223/2009 on Cosmetic Products – Includes distribution requirements for APIs used in cosmetic products within the EU, ensuring compliance with GDP principles.

    4. Directive 2011/62/EU (Falsified Medicines Directive) – Establishes requirements for the supply chain of medicinal products, aiming to prevent counterfeit medicines and ensure the quality and integrity of medicines through proper distribution practices.

    5. Regulation (EC) No 726/2004 – While primarily focused on the authorisation of medicinal products, this regulation also addresses the distribution and traceability of pharmaceutical products within the EU, aligning with GDP.

    6. European Medicines Agency (EMA) Guidelines – The EMA provides specific guidelines on the distribution of medicines, ensuring GDP compliance across EU member states.