Annual Review 2006

GMP News No. 926: Annual Review 2006

GMP News
18 April 2007

Annual Review 2006

Membership – Positive Development and New Opportunities

As in the past years, membership in the European Compliance Academy (ECA)developed very positively. The academy strengthened its reputation as theleading European association with regard to GMP and FDA compliance. Today,we have more than 3.000 members from 50 countries across Europe and abroad.

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So far, it was possible to become ECA member through attending a regularECA course or conference (exception: participation in ECA webinars).Starting in January 2007 this changed – in addition to automaticallybecoming member by participating in an event, the Academy now also offerstwo new membership opportunities: individual membership and companymembership, including all sites in a country. This started very positive andwe already received applications for individual membership and also forcompany memberships, including applications from internationally operatingcompanies in the first two months of 2007. This big interest also supportsthe notion of ECA's impressive reputation. In 2007, we will further promoteand advance these opportunities. For instance, global players in thepharmaceutical industry will be able to sign up for worldwide membership,granting all employees around the globe the membership benefits. Due tothe company Membership we expect an increase of Members of up to 30% in2007.

Foundation of Two New Interest Groups

The year 2006 also marked the foundation of two new interest groups: inJune the ECA established the ECA Rapid Microbiological Methods (RMM)Working Group at the German Federal Agency for Sera and Vaccines. Thisnon-political, independent and science-based group is unique in Europe. Itsgoal is to exchange knowledge and opinions between industry and regulatoryauthorities on an expert level,thereby helping both get a better understanding of the requirements forthe introduction of RMMs and supporting the application of advancedmicrobiological methods in Europe. Currently it counts 11 representativesfrom the European Pharmaceutical Industry and the German Federal Agency forSera and Vaccines, the Paul-Ehrlich-Institute (PEI).

During its annual meeting in July, the Advisory Board decided toestablish the European QP Association. With this membershiporganisation the ECA wants to provide QPs in Europe with a platform allowingthem to exchange experience, discuss latest regulatory requirements, toidentify and address difficulties and challenges and to support a harmonisedEuropean approach. The association is lead by the four ECA Advisory BoardMembers Dr Bernd Renger, Qualified Person, Germany, Richard Bonner,Qualified Person, UK, John Taylor, MHRA, UK, and Rudolf Völler, Office ofthe Darmstadt Administrative District, Germany, as well as Dr ChristopherBurgess, Qualified Person, UK. In November 2006, Dr Bernd Renger was namedChairman of the association.

The interest in the group throughout Europe and beyond underlined theimportance of the newly formed association. More than 150 delegates from 26countries attended its first meeting, the QP Forum held in the fall, toshare experience and discuss the critical areas of the QP's daily work aswell as roles and responsibilities of the Qualified Person withrepresentatives from EMEA and national authorities.

Only six months after its foundation, the European QP Association alreadycounts more than 600 members from more than 30 countries. Find out moreabout the European QP Association.

GMP In-house Training – 2006 another Successful Year

With respect to in-house training courses, the past year tied in with theprevious years. Again, the European Compliance Academy conducted numeroustrainings. We offer this service in cooperation with CONCEPT HEIDELBERG andrely on a pool with high-level speakers who are specialised in various areasand who are professionally, methodically and didactically top qualified –guaranteeing high quality trainings.

CD-ROM "GMP Navigator" – New Release 9.0 under New Name

Traditionally, the GMP Navigator CD-ROM is a very unique anduseful tool. The new release 9.0 was issued in February under the new name"GMP Guideline Manager". Like in the years before, this version containsmore than 800 guidelines from

  • FDA,
  • EC,
  • PIC/S,
  • ICH,
  • WHO and
  • GHTF,

comprising several thousand pages of regulations. It also holds the FDAWarning Letters from the past 3 fiscal years. Through a comfortable searchfunction users can browse the complete CD content by key words and directlyretrieve guidelines and regulations they are specifically interested in.

The free of charge CD-ROM is an exclusive service for ECA event attendeesand members. Company members receive a multi-user licence of the GMPGuideline Manager software.

GMP Certification Programme – Increasing Awareness

The ECA Certification Programme continued to experience an increasingawareness in 2006. Professionals rely on the high-quality programme toadvance their knowledge and to get an additional qualification – making it aconstant for GMP professionals. Today, ECA offers the followingqualification levels:

  • ECA Certified Validation Manager
  • ECA Certified Quality Assurance Manager – Pharmaceutical Production –
  • ECA Certified Quality Assurance Manager – API Production –
  • ECA Certified Quality Control Manager
  • ECA Certified Pharmaceutical Engineering Manager
  • ECA Certified Computer Validation Manager
  • ECA Certified Regulatory Affairs Manager

As in the previous years we'll further develop the programme to offer newcertifications.

ECA Working Programme 2007

The ECA is based on voluntary work of its members and Advisory Boardmembers. This will not change in 2007.

The following activities are planned for 2007:

  • Extension of strategic partnerships with interest groups and universities– expanding the network.
  • Promotion of the free of charge multi-user version of the GMP GuidelineManager for ECA company members.
  • Establishment of the GMP Forum for Medicinal Products as the mostimportant forum in this area in Europe in cooperation with the University ofHeidelberg.

Advisory Board Members

Unfortunately, just recently we lost a great friend and true partner inthe ECA Advisory Board. Mike Edgington, aged 54 years, passed away on7 January 2007. We still don't really want to realise this loss and the gaphe leaves, personally and professionally. Apart from his enormous knowledgewhich he employed to make great contributions to ECA activities, Mike wasalways straightforward and very helpful. The founding of the first ECAWorking Group on Rapid Microbiological Methods (RMM) is due to a great dealto his commitment and dedication.

The Advisory Board Members are:

Active pharmaceutical ingredientsMattMoran, IPCMF, Ireland
Computer validation (incl. Part 11)DrWolfgang Schumacher, F. Hoffmann-La Roche, Switzerland
GMPsupervision Rudolf Völler, Regierungspräsidium Darmstadt, Germany
JohnTaylor, MHRA, United Kingdom
Analytical quality control DrLudwig Huber, Agilent Technologies, Germany
DrBernd Renger, Vetter Pharma-Fertigung GmbH, Germany
Microbiological quality controlColin Booth, Oxoid Ltd, United Kingdom
Quality AssuranceRichard Bonner, formerly with Eli Lilly, United Kingdom
Regulatory AffairsDrBoris Pimentel, DNP (DSM-Nutritional Products), Switzerland
FDAComplianceDaniel Scheidegger, Genzyme Pharmaceuticals, Switzerland

Daniel Scheidegger
Chairman, European Compliance Academy (ECA)


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