Foreword: The importance of good distribution practice
Posted: 3 September 2015 | David Elder (JPAG member and consultant)
Historically, the regulation and control of medicinal products has relied on national and supranational guidelines covering good manufacturing practice (GMP). However, the quality of these medicinal products can be adversely affected by a lack of adequate control over the myriad activities that occur during the distribution process. In addition, the necessity for developing, establishing and maintaining an adequate control system has not generally been well understood. This may result in differences in documentation practices and handling requirements, as well as complex communication between the various organisations, companies, groups or entities that comprise the supply chain.
This is where good distribution practice (GDP) comes in. The US Pharmacopeial Convention believes that GDP should “facilitate the movements of drug products throughout a supply chain”, while the European Medicines Agency has stated that GDP ensures “the level of quality determined by GMP is maintained throughout the distribution network, so that authorised medicines are distributed to retail pharmacists and others selling medicines to the general public without any alteration of their properties”.
Like GMP, GDP is regulated and controlled by numerous national and supranational guidelines. It is reliant on a series of inter-connecting quality systems operated by wholesalers or distributors of pharmaceutical drug products. The systems ensure the following: distributed products are authorised in accordance with the relevant legislation; appropriate storage conditions are maintained at all times, including movement of goods between various parts of the distribution network; contamination by other products is avoided; an appropriate turnover of stock takes place; and that products throughout the distribution chain are stored in safe and secure areas. In addition, to help combat counterfeiting, there should be a system(s) to enable faulty products to be rapidly found and recalled. In parallel, an effective quality system is required to ensure that the right product is delivered to the right location within a designated time period…