FDA provides information about influence of wheather conditions on biological products
The FDA's CBER provides information on the impact of severe weather conditions on biological products, e.g. Vaccines, blood and plasma. More details can be found here.
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 Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) has published a press release about the PIC/S’s meetings held in Ukraine from 30 September to 5 October 2012. What's new in the PIC/S?
Medical Devices Warning Letter Statistics 2012 - Rank 1 for CAPA and Complaint Files
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.
New EU-GMP Chapter calls for Continuous Improvement
One new approach now introduced in the EU-GMP Guide is continuous and continual improvement. It is one important part for allowing "consistent delivery of products with appropriate quality attributes". Read more.
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.
GMP compliance and manufacturing problems may lead to supply shortages of medicinal products in Europe. On 4 October 2012 the EMA published a Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems. Go here to read more.
New rules for Medical Devices published by the EU - significantly tightened Controls planned
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
The European Medicines Agency (EMA) is on track to meet core business targets for 2012 - according to the Executive Director reports to Management Board. Read more.
WHO publishes revised Draft Guideline on Quality Risk Management
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.
FDA requires Registration of Manufacturing Facilities until December 2, 2012
In a Federal Register Notice dated October 2, 2012 the FDA is notifying companies who manufacture generic drug products and Active Pharmaceutical Ingredients as well as certain other sites and organisations that support the manufacture or approval of these products to self-identify themselves with FDA. Go here to read more.
Handling of Deviations and CAPA criticised by Inspectorates
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.
EU: new Delegated Act on Shipments of Medicinal Products through EU
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.