European Compliance Academy for GMP and Regulatory Affairs

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ABOUT THE EUROPEAN COMPLIANCE ACADEMY

With close to 4,000 members the European Compliance Academy (ECA) has become the leading European association with regard to GMP and regulatory compliance. Read more.

Quality Risk Management / Pharmaceutical Quality System

Budapest, Hungary
21-23 April 2010

Find more information here.

EudraGMP DATABASE

Quick link to access the Community database containing information on manufacturers, Manufacturing and Importation Authorisation and GMP Certificates. The read-only access to EudraGMP can be found here (external link).

LATEST GMP NEWS

03/02/2010
EC Commission Publishes Draft on the Creation of a Site Master File
The new draft by the EC Commission to create a Site Master File concerns all pharmaceutical enterprises. The Site Master File is the basis with which the supervisory authorities prepare for a GMP inspection. Here you can read more about the planned changes.

03/02/2010
New CAPA Guidance Published
A concrete instruction for the implementation of the CAPA requirements cannot be found in the hitherto existing guidelines. Here, a newly proposed guidance by the GHTF can help. Read more here.

03/02/2010
Current Status of the Counterfeit Directive in the EU Parliament
The proposed directive about counterfeit medicines contains a number of provisions which will have a major impact for the GMP environment. In December 2009 the EU parliament published a draft report. Read more here.

03/02/2010
Recent Changes Concerning the USP Dissolution Performance Verification Test
On 1 December 2009, changes of the USP regarding the Dissolution Performance Verification Test came into force. Besides the General Chapter <711> was revised. Details can be found in our news item.

27/01/2010
PIC/S publishes Example of Methodology for the Implementation of Quality Risk Management (QRM) in pharmaceutical Industry
PIC/S published in the beginning of January a 30-page document as an example of a methodology for the implementation of Quality Risk Management (QRM) in pharmaceutical industry. Read more about this document here.

27/01/2010
European Commission Publishes Proposal for Part 3 to the EC GMP Guide
On 4 January, the European Commission published a proposal for Part 3 to the EC GMP Guide. Part 1 concerning medicinal products and Part 2 for active pharmaceutical ingredients already exist. Part 3 now includes requirements on a Site Master File. Here you can read more.

27/01/2010
FDA Publishes Statement on the Frequency of Media Fills
In the document "Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs", the FDA publishes statements on topical subjects. Recently, the authority published a statement on the number of annual media fills in relation to the number of shifts and depending on the use of isolators. Find more here.

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List of all GMP News	List of all forthcoming GMP training courses and conferences
List of in-house training courses	GMP Certification Programme

ECA ACTIVITIES

29/07/2009
As of now you can integrate the ECA website into the Google home page (gadget) and in addition use the news as RSS feed. Find out more here.

13/10/2008
As the European Compliance Academy (ECA) announced accepted Dr Sven Deutschmann his appointment as new Chairman of its Working Group for Rapid Microbiological Methods (RMM). Read more here.

22/10/2007
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate clinical studies. A new education course initiated by the ECA now covers all aspects to consider and is supported by the two industry organisations. Find out more here.

14/06/2007
ECA supports a new publication series intended to facilitate the implementation of current GMP guidelines in pharmaceutical operations. The first issue of the "GMP REPORT" covers "FDA Requirements for cGMP Compliance". Twelve Authors from the pharmaceutical industry illustrate the efficient implementation of FDA's cGMP requirements in routine operations. To get more information on the reports and the content of the first issue please see here.

02/04/2007
The Active Pharmaceutical Ingredients Committee (APIC) and the European Compliance Academy (ECA) recently signed a cooperation agreement with the goal to bundle the strengths of the two organisations’ respective areas and to maximise the benefit for the potential target audience in the industry with their activities and conferences. Find out more here.

08/03/2007
Concept Heidelberg has been analysing the FDA Warning Letters on behalf of the European Compliance Academy (ECA) since the fiscal year 2003. Now the new report on the fiscal year 2006 is available as handbook and CD. Get more information here.

19/02/2007
In addition to automatically becoming a member by participating in one of the ECA courses or conferences marked with ECA (exception: Webinars), the Academy now also offers two new membership opportunities - individual membership and company membership.

15/12/2006
The European QP Association, initiated by the ECA in July, announced that it extended its Advisory Board and nominated Dr Christopher Burgess. To find out more, please read here.

15/12/2006
ECA's Working Group on Rapid Microbiological Methods (RMM) experiences tremendous interest. Now the group offers memberships to anyone involved in RMMs. Get the details here.

30/11/2006
ECA's Rapid Microbiology Methods (RMM) Working Group, founded in 2006, currently works on a Best Practice Guide for RMMs. Now the Academy appointed an editorial review board for its guide. Get more information here.