Industry news

Revised EU GDP Guideline Published

The EU published the final version of their revised Good Distribution Practices (GDP) guideline on Friday 8 March. At first glance this final version looks very similar to the draft that was published in 2011.

The revised guidelines introduce the following changes:

• The maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities
• Suitable documentation which prevents errors from spoken communication
• Sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible
• Adequate premises, installations and equipment to ensure proper storage and distribution of medicinal products
• Appropriate management of complaints, returns, suspected falsified medicinal products and recalls
• Outsourced activities correctly defined to avoid misunderstandings
• Rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport
• Specific rules for brokers (persons involved in activities in relation to the sale or purchase of medicinal products).

The revised guidance becomes effective 6 months from the date of publication.

This development will be included in our Pharmaceutical Legislation Update course on 9 April; for details follow this link