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ABOUT THE ECA FOUNDATION

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.

DATABASES ON GMP INSPECTIONS

NEW: FDA Warning Letter Tree

EudraGMP database (EMA)

WHO inspections (WHOPIR)
In a “Concept Paper” from 2010 the European Medicines Agency (EMA) announced that they would revise their Note for Guidance on Process Validation from 2001. This revision’s goal is to implement modern aspects (“enhanced approach”) to move towards a “continuous process verification.

To find out what the industry thinks about this approach, the European Compliance Academy (ECA) conducted a survey in September 2011. More than 500 professionals provided their input to the survey. The results were mailed to the EU Commission and the EMA. Here you will find this letter summarising the survey results.

NEW
Two videos will allow you to get an impression about the ECA Foundation and its comprehensive services as well as about the social events as part of every course and conference - providing the ideal platform for exchanging experience and for networking. Please go here the watch the videos.

LATEST GMP NEWS

25/01/2012
Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment
The Directive on the prevention of the entry of falsified medicinal products into the legal supply chain obliges the EU Commission to adopt the guidelines and principles of good manufacturing practice for APIs by means of a delegated act in form of a directive. In a first step, the Commission has published a concept paper for comment. Read more here.

25/01/2012
Report of the HMPC Meeting held in November 2011
The EMA has published the report of the 44th meeting of the Herbal Medicinal Products Committee (HMPC). In 2011, 20 final monographs were adopted and 21 draft monographs handled. More information here.

25/01/2012
Pharmeuropa publishes a Draft Monograph on "Biological Indicators"
On 15 December 2011, the draft of the revised monograph 5.1.2. "Biological Indicators in the Preparation of Sterile Products" (formerly "Biological Indicators of Sterilisation") was published for comment in the Pharmeuropa until 31 March 2012. More information here.

25/01/2012
Short-term Revision of USP Chapter on Dissolution Testing
A short-term revision of the USP Chapter on Dissolution Testing has been necessary as the reference standard tablets mentioned in it are no longer available. Read more here.

18/01/2012
Inadequate Validation of Analytical Methods remains permanent Topic in Warning Letters to API Manufacturers
The use of not validated or inadequate analytical procedures and the lack of a GMP compliant qualification of analytical instruments - these are violations against basic GMP regulations in the analytical lab the FDA keeps on finding during inspections of API manufacturers. Read more about the analysis of API Warning Letters in the past fiscal year - here.

ECA ACTIVITIES

14/06/2010
The ECA and the European QP Association are currently evaluating the possibility of running training courses on European GMP requirements and the role of the QP outside Europe, amongst others in the U.S.A. Please read more here.

14/05/2010
With the beginning of 2010 the European Compliance Academy (ECA) was transferred to the ECA Foundation (see also News from 14 April 2010) - comprising a non-profit educational organisation, the ECA Academy, and two non-profit interest groups. To get an update on the latest developments with regard to the ECA, please see the video address of Daniel Scheidegger, ECA Foundation Chairman - here.

04/05/2010
To allow students to attend ECA Conferences and Education Courses, the ECA Foundation now offers a Student Programme with special fees. Read more here.

21/04/2010
European Compliance Academy (ECA) nominates Dr Jean-Denis Mallet as new Advisory Board Member. Please see here for more information.

14/05/2010
With the beginning of 2010 the European Compliance Academy (ECA) was transferred to the "ECA Foundation". Get the details here.

30/03/2010
For 2010 the ECA Working Group on Rapid Microbiological Methods (RMM) has planned various activities. To find out more about the planned programme, please read here.

24/03/2010
In April 2008 the European QP Association started its shared audits initiative. Now the Association released its new database "QPSHARE", enabling QPs to find potential partners for sharing audits more easily. Read more here.

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.