Good Distribution Practice (GDP) concerns the distribution processes for pharmaceutical products that results in medics and patients obtaining access to the medications required. For the pharmaceutical organization, the distribution process occurs both upstream and downstream. Upstream are the suppliers who create goods and services used in a manufacturer’s own operations, such as raw components or materials. The downstream supply chain efficiently distributes a company’s products or services to its customers. Each stage, both upstream and downstream, needs to be proactively managed to ensure quality.
These distribution processes concern supply chain, including cold supply chains (where required), and the tracking and tracing of medicines. Traceability includes ensuring that the required environmental controls are met, and that tampering or fraudulent activities are avoided, to the level that each induvial item can be traced from the completion of manufacture to its arrival with the end user. The distribution network for medicinal products is invariably complex and it involves many different parties at different stages. In addition to the challenges associated with this complexity and with protecting the product from being affected by environmental conditions, damage, or loss, there is also a threat from criminal activities centred on seeking to introduce falsified medicines into the supply chain.
GDP requirements are designed to codify and to structure the processes. GDP should be designed around quality management principles and risk considerations. In assessing the requirements for GDP, there are different national and supranational standards to note.
- In the US GMP is based on the Code of Federal Regulations 21 CFR 210/211, with additional guidance contained within USP chapter 1079 “Good Storage and Distribution Practices for Drug Products.
- For Europe GDP is based on the Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption, supported by guideline 2015/C 95/01 (European Commission, 2015), and the Falsified Medicines Directive, which requires a unique identifier and an anti-tampering device to allow the verification of the authenticity of medicinal products.
- With the World Health Organization, the applicable text is Annex 5 of the WHO recommendations “good distribution practices for pharmaceutical products.”
An overarching area of regulatory concern is with the effectiveness of the incorporation of GDP into the Quality Management System (QMS), a system that applies for both wholesaler and broker. These regulations also require effective serialization. This has required for new strategies, processes, and technologies that allow for a business to, at any time, pinpoint the location and origin of any single drug.