Good delivery practice in pharmaceutical

2011-12-31 15:42

Distribution is an important activity in the integrated supply-chain management of pharmaceutical products. Various people and entities are generally responsible for the handling, storage and distribution of such products. In some cases, however, a person or entity is only involved in and responsible for certain elements of the distribution process. The objective of these guidelines is to assist in ensuring the quality and identity of pharmaceutical products during all aspects of the distribution process. These aspects include, but are not limited to, procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record-keeping practices.The storage, sale and distribution of pharmaceutical products are often carried out by various companies, institutions and individuals. This document sets out appropriate steps to assist in fulfi lling the responsibilities involved in the different aspects of the distribution process within the supply chain and to avoid the introduction of counterfeits into the marketplace via the distribution chain. The relevant sections should be considered by various participants as applicable to the particular role that they play in the distribution of pharmaceutical products.The nature of the risks involved is likely to be similar to that for risks encountered in the manufacturing environment, e.g. mix-ups, adulteration, contamination and cross-contamination. When the distribution chain is interrupted by manufacturing steps such as repackaging and relabelling, the principles of good manufacturing practices (GMP) should be applied to these processes.Counterfeit pharmaceutical products are a real threat to public health and safety. Consequently, it is essential to protect the pharmaceutical supply chain against the penetration of such products. Weak points in the distribution processes of pharmaceutical products provide an avenue for counterfeit as well as illegally imported, stolen and substandard medicines to enter the supply chain. This is a concern in both developed and developing countries. The methods by which such products enter the supply chain have become increasingly complex and have resulted in the development of thriving secondary and grey markets throughout the world. The involvement of unauthorized entities in the distribution and sale of pharmaceutical products is a particular concern. Only a joint approach including all parties involved in the supply chain can be successful in the fi ght against counterfeit pharmaceutical products and, therefore, all parties active in the market should take an active part in collaborative activities.