GMP News - Quality Assurance

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.

In July the WHO has published a revised version of their Guideline "Good Manufacturing Practices for Pharmaceutical Products: Main Principles" for comment. Read on.

The European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Read more about the envisaged changes.

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.

The European Medicines Agency has published a new set of Question and Answers on their website. A whole set of Q&As is dealing with API supplies and the auditing of the respective sites. Read more.