EU publishes final GDP guidelines
pharmafile | March 19, 2013 | News story | Manufacturing and Production |Â Â EC, EU, GDPÂ
The European Commission has published the final version of its long-awaited guidelines on Good Distribution Practice (GDP), replacing an earlier 1994 guide that needed updating to bring it in line with the EU’s Falsified Medicines Directive.
The new guideline – which can be downloaded here – introduces a number of new requirements, not least of which is the extension of its scope to include not only pharmaceutical manufacturers and wholesalers but also brokers dealing in pharmaceutical products.
The overarching aim is to tighten up control of the pharmaceutical supply chain via the use of quality risk management systems, and the final version is largely similar to an earlier draft released for comment in 2011.
Among the key changes to the current situation is the requirement to a set up and operate quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities.
The guide covers personnel – including an update on the Responsible Person (RP) at a wholesaler including a clause indicating that a qualified pharmacist is the ‘desirable’ option for this role – and other factors such as premises and ‘suitable’ documentation to prevent errors caused by spoken communication.
There are also changes to the procedures for management of complaints, returns, suspected falsified medicinal products and recalls and new rules for transport designed to reduce the risk of excessive temperature fluctuations, breakage, adulteration and theft.
It also introduces a requirement for wholesalers to record the batch number of a medicinal product, although the EC stresses this will only apply three years after the adoption of a delegated act on safety features, which is not expected to take place until 2014.
The GDP guideline will enter into force on 8 September 2013.
“Today’s distribution network for medicinal products is increasingly complex and involves many players,” said the EC in a statement.
“The revised guidelines … lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain,” it added.
Phil Taylor
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