GMP NEWS 2013

The Parenteral Drug Association published the revised Technical Report No. 33 on Alternative and Rapid Microbiological Methods. Read more here.

In July this year, the European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". The European QP Association has provided a comprehensive summary as feedback to the proposal. Read more.

Particles in medicinal products for parenteral use as well as the 100% inspection on particles stay in the focus of the US American authorities. There are some upcoming changes in the USP with respect to particle inspection, which you can find here.

When will the new single EU numbering system for ASMFs be obligatory? Can an ASMF holder have more than one ASMF for one active substance? Those questions and other ones have been answered in a new Q&A document on the ASMF procedure published by the CMDh at the end of September. Read more here.

With the proposal of <1664> Assessment of Drug Product Leachables associated with Pharmaceutical Packaging/Delivery Systems, the USP continued their activities regarding the suitability of packaging materials. Read more.

A huge benefit of smartphones and tablet PCs and apps is that you can access relevant information any time anywhere. Now you can also quickly and comfortably access information with regard to news and regulations in the GMP environment - and more. For that purpose the ECA Foundation took advantage of its longstanding experience to develop a free of charge smartphone and tablet PC WebApp. Find out more....

In a new Guideline, the FDA laid down concrete provisions regarding how printed packaging (labels, cartons, etc.) should be designed to ensure the readability of the most important information. The purpose is to enhance the safe use of medicinal products and to reduce the number of medication errors. Read more in the News.

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. Please find more here.

In the USA federal agencies are facing a government shutdown. But what does that mean for the U.S. Food and Drug Agency FDA? Will inspections be performed? And what about submissions? Read more.