Falsified Medicines Directive 2011/62/EC, published in 2011, affects the supply chain security and good distribution practice (GDP) in many ways. For one thing, pharmaceutical companies face more stringent requirements. Holders of manufacturing authorisations are required not only to prove manufacture of an imported active ingredient in accordance with the GMP, but also distribution in line with the GDP.
For all practical purposes, this means that each and every company that plays a role in the supply chain, i.e. retailers, logistics service providers or repackagers, should undergo regular monitoring. Such a requirement is part of the modified version of Directive 2001/83/EC. Part 2 of the EU-GMP Guide applies to GDP audits as well; the relevant Chapter 17 of the Guide should be emphasised during audits. blue has been requiring these fundamental principles for quite a while already, for instance during active ingredients audits, since the actual deficiencies swiftly come under scrutiny by authorities and must be rectified without delay.
In the area of excipients, Directive 2011/62/EC leads to more stringent requirements in the GMP domain as well as in the GDP domain. Relevant rules and regulations exist for excipients such as the IPEC GMP/GDP Guidelines.
For finished medicinal products, a draft of a new EC GDP Guide has been published. This guide extensively broadens the requirements in this area. blue inspection body offers audits based on this directive (e.g. for logistics service providers, retailers).