GMP NEWS 2014

At the beginning of April 2014, the European Medicines Agency (EMA) published a concept paper which describes the need for a revision of the existing documents about complying with the current state of art with regard to terminal sterilisation and aseptic procedures. Read more here

Further information has now been released about EU Commission's delegated acts on the Counterfeit Directive after a workshop involving stakeholders took place on 28 April 2014. Read more here about the recommendations made for the implementation of future safety features.

Dated April 2014 the WHO published a proposal for the revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good Manufacturing Practices. The reason given for the revision is compliance with actual GMP requirements. The following is an in-depth analysis.

GMP Compliance problems found at more and more manufacturers in India are a major concern of EU and FDA regulators. Again the FDA has issued an Import Alert for an Indian Manufacturer. Please read more.

Prof. Schwerdtfeger, president of the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the Federal Institute for Drugs and Medical Devices) has demanded a rethinking in policy and pharmaceutical industry in an interview with the the daily paper "Die Welt". In the interview which has attracted much attention he also talked about the actual supply shortages. Read more about the interview with the president of the BfArM.

The EMA has recently extended its Q&As document with 2 questions/answers about differences between the properties of a generic product and those of an innovator product which could lead to medication errors. Read more here.

Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Read more.

Following the positive vote in Parliament for the new Clinical Trial Regulation, the EU Commission has published a set of Q&As on clinical trials. Read more.

The British Medicines Authority MHRA is performing GMP and GDP Inspections on a risk based strategy. Based on the experience the MHRA answers frequent asked questions. One very interesting Q&A refers to Mean Kinetic Temperature Calculations (MKT). Read more about MKT here