The ECA and the PQG publish two draft chapters on GDP interpretation

The European Compliance Academy (ECA) and the Pharmaceutical Quality Group (PQG) announce the availability of two draft chapters on the interpretation of the new EU GDP Guideline.

The distribution network for medicinal products is often complex, involving many different parties. In addition to the challenges associated with this complexity, there is also a growing threat from criminal activities seeking to introduce falsified medicines into the legal supply chain. The European regulators recognised several years ago that there was a need to update the content of the 1994 Good Distribution Practice (GDP) guideline to take into account advancements in practices and changes in legislation since it was issued. A consultation draft was issued in mid 2011 and, following the receipt of many comments from interested parties, a final revised version of the GDP Guideline was issued in March 2013 with an effective date of 8 September 2013.

The Pharmaceutical Quality Group issued a monograph on Pharmaceutical Distribution in 1997 and initiated planning to revise this in line with the new regulatory guideline. Whilst undertaking this planning it was identified that the European Compliance Academy was also planning to produce some guidance in response to requests from members. The two organisations therefore decided to join forces and set up a joint steering committee led by Afshin Hosseiny with Philip Butson and Ashley McCraight.

An early decision was that the group would initially target key chapters and issue each as it became available rather than wait until a complete guide had been prepared. This has enabled the group to shorten the time to the provision of some guidance and also provides an opportunity for the group to collect feedback and enhance the material before issuing a complete guide. The first versions of the chapters will have different formats and styles due to the different volunteer teams involved in their preparation which we have chosen not to edit into a common format for the time being. The task force would appreciate feedback on what works best for you, the user. Please use the contact details provided in the pdf documents.

The ECA has also set up a new Webpage for the GDP Group: http://www.good-distribution-practice-group.org

Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 1 – Quality Management

Guidance on the interpretation and implementation of European Good Distribution Practice Chapter 9 – Transportation