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.


Changes to Variation Rules started to apply

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.


New EMA Guideline on Specifications for Impurities in Antibiotics

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 Problems may cause Drug Shortages

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.


EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

The EMA/CHMP published an assessment report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines. More details can be found here.


Literature and publications list are updated with 11 publications

The new literature and publication list on the RMM Group website was completed with new interesting reports and publications. Read more here.


RMM database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 4 new systems, e.g. for sterility testing and Endotoxin detection. More details can be found here.


EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation

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.


WHO issues Update of Pharmaceutical Water Guideline

Together with the Technical Report 970 (TRS 970) the World Health Organisation (WHO) also issued an update of the pharmaceutical water guide from 2005. Read more.


DataMatrix Code on Pharmaceutical Packaging - Pilot Project starting in January

The securPharm initiative has announced that a nationwide pilot project will be started from January 2013 in Germany to test safety features. Read more here.


Modification of ISO 13485 - new Annexes ZA, ZB and ZC

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.


QP for Manufacturers of Medical Devices - New EU Requirement?

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.


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


FDA Warning Letter Statistics 2011 with regard to Process Validation / Qualification and Calibration

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.


EMA on Track to meet Targets

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.


Draft Guideline on Good Distribution Practices for Biological Products published by CDSCO

The Central Drugs Standard Control Organization (CDSCO), the Indian Authority for Medicinal Product published a draft Guideline on Good Distribution Practice (GDP) for biological products. 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.


Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

The European Medicines Agency (EMA) has published an additional Guidance document relating to Active substance Master Files (formerly known as European Drug Master File). Find out more.


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.


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