Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline
The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs). Please read more about the new Questions and Answers on GDP
Chapter 15, which is relevant for medicinal products, has been supplemented by further details on the promotion of collaboration between the individual supervisory agencies and inspectorates. Companies will be better informed now, as well.
Will there be an ISO Standard for Refrigerated Parcel Deliveries?
The British Standards Institution (bsi), Group Japan, has developed a so called PAS (Publicly Available Specification) to specify requirements for temperature-controlled delivery services for chilled and frozen goods.
GDP Guidelines are certainly a hot topic in the EU and in WHO states. In the US, things are still developing but are getting more and more important, as the excerpts from recent Warning Letters addressing GDP isssues show.
Violation of GDP Guidelines and Counterfeiting of Medicines - a Current Case Demonstrates the Dangers
The trade press has extensively covered the counterfeit of Harvoni, a pharmaceutical produced by Gilead. The background circumstances as well as the consequences to be drawn from this incident are of interest here. Read more about the counterfeit case and the GDP consequences.
European GDP Association nominates two new Advisory Board Members
The European GDP Association has been growing steadily since its foundation as Good Distribution Practice Interest Group in 2013. Now it represents close to 1.900 professionals from all over the world. Recently the Association announced that two new members joined the Advisory Board.
After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future.
FDA's new automated system to assist in making import decisions for FDA-regulated products seems to shorten up processing time, according the agency. Learn more about the FDA Automated Commercial Environment/International Trade Data System.