ECA's 12th Annual Review (2010)
Annual Review 2010
ECA established as Foundation
For the past ten years the European Compliance Academy (ECA) was lead as a membership organisation. With the beginning of 2010 the organisation was transferred to a Foundation. The goal remains the same as before: “The information exchange between representatives of the industry, the medicines authorities and the universities in the field of pharmaceutical quality assurance, especially with regard to the area of Good Manufacturing Practice (GMP)."
The Foundation continues to be lead by an advisory board with 10 members from industry and authorities. It is comprised of a non-profit educational organisation and two non-profit interest groups. The ECA Academy as the educational organisation part is providing GMP Conferences as forums for exchanging information between industry, authorities and academia as well as education courses and advanced trainings as part of the "ECA GMP Certification Programme". Moreover, the European Qualified Person (QP) Association represents the interests of individual Qualified Persons (QPs) in Europe and supports a harmonised approach for all EU Member States. The second interest group, the "Rapid Microbiological Methods Group" supports the idea of the use of rapid microbiological methods and a harmonised approach in the EU and the USA.
Throughout the year the organisation continued to grow – to almost 4.000 members by the end of 2010.
As memberships are gained automatically by attending an ECA course or conference this number showed the growing interest in ECA’s advanced training programmes.
The ECA further counted around 70 individual members from 30 countries and gained 10 company members.
In addition, the organisation counted close to 50 members via the one year individual membership and close to 10 company membership from companies throughout Europe and beyond.
ECA Interest Groups continue to grow
Throughout 2010 the interest in the European Qualified Person Association still continued to grow. By the end of the year the association had more than 1.350 members.
In 2010 the well established QP Forum – today the major event for QPs from all over Europe – included a first time full day pre-conference workshop on audits bringing together the players from the major international authorities and industry organisations. This pre-conference was conducted in addition to the half day workshop on the specific requirements for IMPs, which the IMP group organised for the third time.
In March the QP Association also released the next generation of its shared audits database – “QPSHARE”. The database was revised to increase convenience and displays potential suppliers more than one QP is interested in. Members of the European QP Association are now able to identify suppliers and the number of QPs interested in auditing the supplier. Confidentiality is maintained as the names of the QPs is not displayed. If a member would like to contact the QPs related to a certain supplier, a button allows the member to send an automatic message to the other QPs. Only if the QPs who receive the message are interested they may disclose their identity and contact the colleague.
Alike the QP Association the Rapid Microbiology Method (RMM) Group has been experiencing an increasing awareness. By now, the group counts more than 300 members from Europe and abroad.
The first time RMM Conference conducted in 2009 attracted more than 80 delegates. With more than 60 delegates in 2010 the conference came close to the number of delegates one year before.
In November the group added further systems to its RMM database, which now comprises 26 different systems and provides members with the opportunity to search and compare them by selection of criteria like Application, Analysing Methods, Detectable Microorganisms and more criteria.
During its meeting in January 2010 the Advisory Board discussed a number of issues within the quality control environment – and, as a result, decided to establish the Analytical Quality Control Group which was founded in November. This new group aims at providing a networking platform for Analytical Chemist and Scientists and to facilitate an active discussion of the latest regulatory requirements as well as identifying and addressing technical issues and challenges. In addition it wants to support a harmonised approach through providing discussion/position papers and generic procedures via expert working groups and to foster an effective and efficient communication between industry, competent authorities and the pharmacopoeias.
The group defined the generation of a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE, and OOT results as its first project.
New edition of the EU GMP Guide Paperback
In March a new edition of the EU GMP Guide was issued as paperback version. It does not only contain the current Parts 1 (Medicinal Products) and 2 (APIs) but also the new draft Part 3 (Site Master File). The new version also comprises the latest changes in Annex 3 and 7.
New Version 12.0 of the GMP Guideline Manager released with new features
The GMP Guideline Manager Software contains over 1,100 GMP guidelines, including FDA, EC, PIC/S and ICH as well as Good Practice Guides from major organisation such as APIC/CEFIC and IPEC. The new version 12.0 was released in April.
Version 5 of the "GMP/ISO Matrix"
Version 5 of the ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -" became available in May.
ECA GMP Certification Programme
In 2010 the acknowledged programme was extended from seven to eleven certification programmes and now provides professionals with the opportunity to advance their knowledge and complete an additional qualification in even more areas. The added programmes are:
- ECA Certified Microbiological Laboratory Manager
- ECA Certified Sterile Production Manager
- ECA Certified Pharmaceutical Development Manager
- ECA Certified Biotech Manager
To learn more about the programme please see GMP and GDP Certification Programme.