Issue link: https://www.e-digitaleditions.com/i/1462272
24 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com A New Route to Pharma GDP Compliance and Standardization A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines. T he logistics associated with the safe and effi- cient physical transportation of pharmaceuticals is increasingly taxing the minds of logisticians as medicines become more complex and labile and their regulatory oversight intensifies. The statu- tory need to maintain the therapeutic and physical integrity of drugs during transit renders the management of quality and the adherence to good distribution practice (GDP) guidelines an absolutely critical part of the pharmaceutical supply process. GDP'S EUROPEAN ORIGINS In 2001, the European Union issued Community Code Directive 83 (1) defining a framework for the harmonization of the regulations relating to medicines including the rules gov- erning their distribution. As far as GDP is concerned, this code built on the original EU GDP guidelines of 1994 (2) and has culminated, amongst other things, in the revised EU guidelines of November 2013 for human medicinal products (3) and the guidelines for APIs of March 2015 (4). However, although the EU guidelines that were introduced in 2013 have formed a template for many subsequent national regulations, even within the EU the exegesis of GDP is open to wide interpretation. To a large extent, this is because GDP is (necessarily) non-prescriptive in nature and the guidance has been enacted in the form of a community directive rather than a regulation. This places responsibility in the hands of 'National Competent Authorities' which govern the authorization of COURTNEY SOULSBY is sector director, Healthcare & Life Sciences, BSI. ALAN KENNEDY is director, Team Poseidon. COURTNEY SOULSBY AND ALAN KENNEDY Quality and Regulatory Sourcebook Regulations: Supply Chain Fabian - Stock.adobe.com