Revision of the USP Chapter on Packaging and Storage Requirements
The proposed revision of Chapter <659> on Packaging and Storage Requirements shall help ensuring in the future that the definition of the "single-dose-containers" term is used correctly. In addition, the storage conditions for medicinal products have been defined completely. Read more here in the News.
FDA started Initiative for DUNS Numbers of Pharmaceutical Sites
In one of our last News, we reported about the DUNS numbers for the identification of pharmaceutical sites in Site Master Files. Last year, the FDA also started an initiative for the DUNS numbers. Read more.
Have you ever heard about the Dun and Bradstreet Verification in the EU Site Master File?
With the binding mention of a Site Master File in revised Chapter 4 of the EU GMP Guide, the document has become obligatory for all pharmaceutical companies. The EU Site Master File contains a few essential changes to the previously applicable PIC/S Guideline PE 008-3. In the new version for example under section ... read on.
EU-GMP Guide: final Chapter 2 on Personnel published
The European Commission has published the revised Chapter 2 on Personnel, which will come into operation on 16 February 2014. The basic principles of the chapter have been unchanged; however a few new approaches have been added. Read more.
Frequently we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). For that reason you can now find explanations to the three most important documents in this news.
Globalisation of Manufacturing and Distributing Medicinal Products Causing Troubles according to the FDA
On the FDA website, you can find the slides of a presentation made by Robert Sklamberg, Director of CDER's Office of Compliance in May 2013. The topic deals with the challenges presented by globalisation of manufacturing and distributing. Read more here.
The ACAA between the EU and Israel entered into force on 19 January 2013. It is a framework agreement that recognizes Israeli industrial standards as equivalent to European standards and is similar to a Mutual Recognition Agreement (MRAs). Read more.