Annex 5 WHO good distribution practices for pharmaceutical products

1. IntroductionDistribution is an important activity in the integrated supply-chainmanagement of pharmaceutical products. Various people and entities aregenerally responsible for the handling, storage and distribution of suchproducts. In some cases, however, a person or entity is only involved in andresponsible for certain elements of the distribution process. The objectiveof these guidelines is to assist in ensuring the quality and identity ofpharmaceutical products during all aspects of the distribution process. Theseaspects include, but are not limited to, procurement, purchasing, storage,distribution, transportation, repackaging, relabelling, documentation andrecord-keeping practices.The storage, sale and distribution of pharmaceutical products are oftencarried out by various companies, institutions and individuals. Thisdocument sets out appropriate steps to assist in fulfilling the responsibilitiesinvolved in the different aspects of the distribution process within the supplychain and to avoid the introduction of counterfeits into the marketplacevia the distribution chain. The relevant sections should be considered byvarious participants as applicable to the particular role that they play in thedistribution of pharmaceutical products.The nature of the risks involved is likely to be similar to that for risksencountered in the manufacturing environment, e.g. mix-ups, adulteration,contamination and cross-contamination. When the distribution chain isinterrupted by manufacturing steps such as repackaging and relabelling,the principles of good manufacturing practices (GMP) should be applied tothese processes.Counterfeit pharmaceutical products are a real threat to public healthand safety. Consequently, it is essential to protect the pharmaceuticalsupply chain against the penetration of such products. Weak points inthe distribution processes of pharmaceutical products provide an avenuefor counterfeit as well as illegally imported, stolen and substandardmedicines to enter the supply chain. This is a concern in both developedand developing countries. The methods by which such products enter thesupply chain have become increasingly complex and have resulted in thedevelopment of thriving secondary and grey markets throughout the world.The involvement of unauthorized entities in the distribution and sale ofpharmaceutical products is a particular concern. Only a joint approachincluding all parties involved in the supply chain can be successful in thefight against counterfeit pharmaceutical products and, therefore, all partiesactive in the market should take an active part in collaborative activities.Different models for the distribution of pharmaceutical products are usedin different countries and sometimes within the same country, for example,236