Press Announcements 2011

New Version 13.0 of the Guideline Manager Software available

The GMP Guideline Manager Software is one of the most attractive benefits for ECA Members and is an exclusive and free of charge service for individual and company members. Individual members receive the single user CD, company members a multi-user version for installation on the company server. The fee for individual membership is 190,- EUR, the fee for company members depends on the number of employees. Find out more about the membership benefits.

Consequences of the new Pharma Directive for Quality Assurance/GMP Department

On February 16, 2011 the EU Parliament adopted an amendment to the Directive 2001/83/EC. This Directive will have a major impact on the GMP environment e.g. because of more stringent rules for APIs and Excipients, GMP inspection of traders and wholesalers as well as new safety features on the packaging of medicinal products. This is why the ECA Foundation invited representatives from the European Medince Agency (EMA) and from the most important interest groups such as EFPIA, APIC/CEFIC, IPEC, QP Association to discuss the consequences at the conference "The New Pharma Directive" taking place in Berlin, Germany, from 5-6 October 2011. For further details please see the programme and the information about the new directive.

Annual Meeting of the Rapid Microbiological Methods Group Advisory Board

On 17 February, the Advisory Board of the Rapid Microbiological Methods Working Group held its annual meeting in Penzberg Germany. More details and the outcome can be found here.


ECA Comments to the EU Commission - Survey on EU GMP Chapter 5 & 7 Revision

As mentioned in the last newsletter, the ECA would like to get your thoughts on the revision of the EU GMP Guide chapters 5 and 7. Thus, if you haven't had a chance yet to complete our survey, we would like to encourage you to do so.

Revision of EU GMP Chapter 5 & 7 - Be involved in ECA`s comments to the EU Commission

Chapter 5 "Production" and Chapter 7 „Outsourced Activities“ of the EU GMP Guide were revised and recently published on the European Commission's GMP information page. The ECA  would like to get your thoughts on this revision and thus would appreciate it if you took about 5 minutes to complete our survey

Register for only 490,- Euro and join 5 Sterile/Aseptic Technology Conferences

Europe´s leading Pharma Congress on Pharmaceutical Technology will be held in Duesseldorf, Germany, on 22/23 March 2011. Case Studies from Boehringer Ingelheim, Eli Lilly, Roche, Genentech, Novartis, and many others will be presented in parallel Conferences. You will find the detailed programme at

New ICH Q7 "How to document" (Version 6) from APIC now available in our book shop

One of the most important and useful documents issued by the European Association of API Manufacturers (APIC) is the so-called "How to do" Document. This paper interprets the ICH Q7 Guide’s GMP requirements manufacturers of active ingredients have to fulfil. You can purchase the book here.

Speakers from China FDA, WHO, AFSSAPS and MHRA confirmed

Only every 2 years the ECA, the QP Association and the University of Heidelberg organise the European GMP Conference. This unique event offers five sessions on current GMP topics under the motto: "Industry meets Authorities". Please read more at

Questions and Answers on GMP eLearning

The feedback on the announcement of a GMP eLearning System has been so huge that we have decided to compile the frequently asked questions in a document. You can find the document here.


Databases on GMP Inspections

Do you want to find out whether a certain company (e.g. your supplier) was inspected by an GMP authority? On the ECA website you will have direct access to EudraGMP (Database of the competent authorities in the EU) and WHOPIR, the inspection site of WHO. You will also find the FDA Warning Letter Tree. This new service, which is only available on the ECA Webpage, allows you to access only the GMP relevant Warning Letters which have been categorisd according to fiscal years and product groups (Drugs, Biologics/Blood, APIs). Here you will find the databases:

GMP Conferences by Topics