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.
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.
A new EMA Guideline on impurities of APIs manufactured by fermentation with eventual further synthetic steps defines precise requirements with regard to the information that has to be provided on these impurities. Read more here in the News.
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.
The European Commission has published a Version 2.0 of the Q&A document "Importation of Active Substances for Medicinal Products for human use" on 26 October. Version 1.0 was published on 10 July 2013. Please read more here.
In order to adjust to the current EU-Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices, EN ISO 13485 will be modified. Many manufacturers of medical devices are certified according to EN ISO 13485 as basis for their management system for the development and production of medical devices. Read on here.
Article 13 of the proposal for a regulation concerning the new regulatory framework for medical devices introduces a new role for manufacturers of medical devices: A person responsible for regulatory compliance. This function, referred to as "qualified person", involves certain requirements as well as responsibilities. Find out 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 the Warning Letter Report 2011, statistics have been published about FDA’s Warning Letters (issued to drugs and API manufacturers) during the fiscal year 2011 (from October 2010 to September 2011). The topics Process Validation / Qualification haven’t been considered separately. In the following, you will find a summary from the 39 Warning Letters 2011 on GMP deviations regarding Process Validation, Qualification and Calibration in the manufacturing environment.
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.
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.