European Compliance Academy for GMP and Regulatory Affairs

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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)

LATEST GMP NEWS

01/09/2010
FDA revises Guidance Document on Pre-Approval Inspections
The U.S. Food and Drug Administration has revised the Compliance Program Guidance Manual on Pre-Approval Inspections. The Guidance document has been completely reworked. Read more.

01/09/2010
New WHO Draft on the Manufacture of Sterile Medicinal Products
With the revision of the WHO Technical Report Series (TRS) No. 957 in June 2010, the WHO's expectations on the manufacture of sterile medicinal products were published as a draft for an Annex 6 "Good manufacturing practices for sterile pharmaceutical products". Read more here.

01/09/2010
New Toxicological Data on Isopropylbenzene Trigger its Categorisation as Class 2 Solvent
Due to new toxicity studies in rats and mice, the solvent Isopropylbenzene is meant to be categorised as Class 2 instead of Class 3. A corresponding ICH draft guideline has been published and released for commenting by the public. Here you will find the details.

01/09/2010
Inspection of Biological Drug Products
The FDA published 2010 the revised Compliance Program Guidance Manual – Chapter 45 Biological Drug Products: Inspection of Biological Drug Products (CBER). More details can be found here.

25/08/2010
FDA publishes Q&As on Drug Recalls
The FDA recently published a set on Q&As on recall procedures in the section Questions and Answers on Current Good Manufacturing Practices. Read more.

25/08/2010
EMA and US FDA seek potential Candidates for joint GMP Inspection Programme
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Read more about the programme.

25/08/2010
Impurities and Setting Specifications - the EMA Publishes Harmonised Policies on Its Q&A Page
Impurities, like heavy metals, residual solvents and genotoxic substances, may have to be included in the drug substance specification depending on the point in time when they are formed or introduced into the synthesis process of an active pharmaceutical ingredient. On this issue, the EMA has described a harmonised policy on its Q&A page. Read more here.

QUICK LINKS

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

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.