GMP News - Quality Assurance

The European Medicines Agency EMA has published a draft concept paper on the revision of Annex 17 (Parametric Release). Read more.

Chapter 2 Personnel of the EU GMP Guide lays down that employees must be instructed on GMP regularly. The challenge raised is how to manage efficiently annual GMP trainings? Read more in the News.

The European Compliance Academy (ECA) annually provides an analysis of the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for fiscal year 2012 (from 1st October 2011 to 30 September 2012). Read more here.

A number of amendments to the Variations Regulation (Regulation (EC) No 1234/2008) that affect the provisions governing centrally authorised medicines started to apply on Friday 2 November 2012. Read more.

The PIP scandal also has influenced the long planned revision of the rules for medical devices in Europe significantly. On 26 October 2012 the European Commission published proposals to ensure that especially patients can reap the benefits of safe, effective and innovative medical devices. The competent commissioner at that time, Mr John Dalli, spoke about significantly tightened controls... Read more

In one of our GMP Newsletters end of September 2010, we referred to a draft guideline of the WHO on quality risk management (QRM). Now, this draft has been revised and published for comment. Click here to read more about the comments made by the European Compliance Academy (ECA) to the WHO.

Deviations and CAPA remain hot topics in inspections. The inspectorates' summaries of their observations show that things do not always work as desired. Read more.