GMP News - Quality Assurance

The  European Commission has published a draft Delegated Act concerning a new requirement of the Falsified Medicines Directive under which medicinal products being shipped through the EU. Read more.

Reviewing FDA's warning letters of the last fiscal year reveals that incompleteness, management and training of Standard Operating Procedures (SOPs) is still a hot topic. Read more.

The European Commission has published the final version of the revised Chapter 1 of the EU GMP Guide, which will now be called "Pharmaceutical Quality System". It includes comprehensive changes. Read more.

The FDA has put into effect the ICH document with points to consider covering topics relevant to ICH Q8, Q9 and Q 10 in July 2012. This guideline is intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment, and inspection related to QbD-applications filed for marketing authorisations. Get the complete news.

The US Food & Drug Administration (FDA) published two Guidances for Industry with regard to Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Find more details here.

In its latest press release, the Pharmaceutical Inspection Co-operation Scheme PIC/S highlighted the outcome of its last Committee Meeting. What are the main news? Read more.

We regularly analyse 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 the first half of the fiscal year 2012 (from 1st October 2011 to 15 March 2012). Read more.