ECA and PQG publish interpretation of the EU GDP guide

The Pharmaceutical Quality Group (PQG) issued a monograph on Pharmaceutical Distribution in 1997 and initiated planning to revise this in line with the new EU GDP regulatory guideline (a final revised version was issued in March 2013 with an effective date of 8 September 2013). Whilst undertaking this planning it was identified that the European Compliance Academy (ECA) 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. Kane Edgeworth (Director, Biomap Ltd) was invited to participate in the working group and contributed to Chapter 9 Transportation.

Interpretation of Chapters 1 & 9 is now available:

http://www.good-distribution-practice-group.org/gdp_news_3973_7940,S-GDP.html

http://www.gmp-compliance.org/enews_03973_.html

http://www.pqg.org/shop/11-guidelines