ECA's 15th Annual Review (2013)
Annual Review 2013
ECA Membership Development
In 2013 the number of professionals participating in ECA courses and conferences climbed to more more than 5.100.
ECA Interest Groups further expand
The European QP Association further grew in 2013 and counted 1.900 professionals by the end of the year. The number of associate members also rose to 265. Altogether the Association now represents professional working as QPs and in similar functions from more than 40 countries.
The Association’s Advisory Board also showed some changes in the last year: Dr Ulrich Kissel, Roche Pharma AG, Germany replaced Dr Bernd Renger on the industry side. Edit Szőcs from the Hungarian National Institute of Pharmacy (NIP) replaced Rudolf Völler from the German Inspectorate in Darmstadt.
In terms of courses and conferences, there were three main events in 2013: two QP Education Courses held in Prague & Barcelona and the QP Forum which was held in November in Lisbon. This time this meeting point for QPs from around Europe and beyond attracted more than 200 delegates.
The IMP pre-conference session has developed as a fixed part of the QP Forum. Prior to last year’s event the IMP group within the QP Association set up the four working teams
GMP in different Development phases
IMP Certification Process
to work out SOPs, workflows and white papers. The results of their efforts were presented during the pre-conference session again and will now be summarized and published in the near future.
In addition the Association’s annual QP course in the USA was conducted for the 3rd time and is well on its way to become a consistent factor. This time the course was held in San Francisco in June and aimed again at educating American colleagues on the role of the QP in Europe.
As in the previous years the Association also conducted surveys to provide feedback to European regulators. Last year, comments were provided with regard to the draft Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release. Comments of course included feedback from EQPA members and were submitted for consideration towards the issuance of the final version in 2014.
QP board members have also routinely been involved in regular telecoms with the EU Commission and other organisations on the importation of APIs. Thus the European QP Association was also represented during last year’s EMA GMDP IWP Interest Parties Meeting in London to represent the voices of European QPs.
The Rapid Microbiological Methods (RMM) Working Group also continued to grow. End of 2013 the group counted 423 members.
In its effort to provide members with information on RMM systems available in the market, the group updated its database which counted 44 systems by the end of the year. Moreover, the pages with regulatory background, literature reports and articles about the different types of Rapid Microbiological methods were also revised and updated. The new structure now shows the three parts Regulatory Documents, Books & Overview Articles as well as Papers on RMM & their Validation.
In terms of conferences the group conducted the combined European Mycoplasma and European Microbiology Conference in Copenhagen in April which close to 100 professionals from 17 countries attended, and the Rapid Microbiological Methods Conferences with a Validation Workshop in Barcelona in December. This event was attended by more than 80 delegates and 12 exhibitors.
With the aim of facilitating its routine use and implementation as a replacement of the test for Pyrogens the EDQM gathered information from all potential users of the Monocyte-Activation Test (MAT) of the European Pharmacopoeia (Chapter 2.6.30). The RMM supported this effort by conducting a survey among its members and forwarded results to the EDQM.
In 2013 the ECA Analytical Quality Control Group counted 140 members from more than 30 countries. After the group’s first version of the SOP Laboratory Data Management; Out of Specification (OOS) Results had been launched in 2012, version 2.1 was approved and released in August and is supposed to be presented during the OOS training course in March 2014. The group also started to work on developing a second SOP on Out-of-Trend Results. A first version is planned for publication in October 2014 – during the OOT Forum.
The ECA’s Process Validation Group mainly concentrated on two items in the past year: since the European Medicines Agency (EMA) issued a very vague concept paper with regard to the EU Annex 15 revision the group wanted to find out more on the industry’s thoughts on this planned revision. For that purpose it conducted a survey in which close to 300 professionals provided feedback – and which was then forwarded to the EMA for improvement of the Annex. The survey and the results were also the basis of discussion in a session during ECA’s European GMP Conference conducted in June. Prior to the conference the group encouraged professionals to exchange information with the ECA Advisory Board members. Results of the discussion are supposed to be implemented in the revision of the group’s Validation Good Practice Guide which will be reviewed after the revised Annex 15 draft will be issued as its new aspects will also be considered in the Guide.
The Foundation’s latest Working Group – the Good Distribution Practice Group – established in the first quarter 2012 launched its new website in fall. On 7 March 2013, the EU Good Distribution Practices (GDP) Guideline was published in the Official Journal of the European Union. Six months later, on September 8, 2013, the Good Distribution Practice Guideline came into operation. Many requirements in the GDP Guideline are not clear and require interpretation. It is the objective of the ECA Foundation’s GDP Working Group to support all stakeholders involved in Good Distribution Practices by providing information on the interpretation of the Guide. In July 2013 the Working Group signed a Joint Venture Agreement with the Pharmaceutical Quality Group (PQG) of the Chartered Quality Institute. Both groups intend to develop a Guideline for interpretation of the EU GDP Guideline. The first two chapters of this Guideline have been published on the GDP Group Webpage.
European GMP Conference
The first GMP rule was published in 1963 by the US FDA to protect the health of drugs’ consumers. Since then, the development of the GMPs has been tremendous. GMP is the accepted worldwide “gold standard” for the manufacturing and control of medicinal products. For that reason the ECA dedicated its 5th biennial European GMP Conference to this 50th anniversary of the first published GMP regulations and the further development of the work towards a harmonised set of GMP regulations for medicinal products. Delegates from more than 20 countries worldwide met in June in Heidelberg to discuss past developments, current challenges and required future advances. In three sessions the work of the ECA’s working groups were in the centre of attention: the Process Validation Group’s as well as the GDP Group’s Good Practice Guides as well as the Analytical Quality Control Group’s 2nd Version of the SOP on OOS.
In 2013 the ECA Foundation took advantage of its extensive experience in providing advanced training and information services to develop a further free of charge service – the new GMP WebApp.
This new GMP WebApp runs on all smartphones and tablet PCs (Apple and Android platforms) and allows users to have GMP information at hand any time and anywhere. Due to its development as a web-based app there are no updates that need to be continuously downloaded. Any time new information is available on ECA’s website the app also displays the latest version.
The app comprises an entire set of features: users have access to all news also issued in the weekly free of charge GMP Newsletter as well as to major GMP Guidelines from authorities worldwide. Moreover, the app provides a comfortable GMP Search function. This function can be used to search simply all ECA databases, just guidelines or course and conference materials.
An additional function is an exclusive service for ECA Members: after login they have access to ECA’s Guideline Manager. Altogether this Guideline Manager includes more than 1.200 GMP Guidelines from EU/EMA, FDA, ICH, PIC/S, APIC, IPEC and WHO. In two webtrees these Guidelines are either displayed according to the issuing authorities or by GMP topics.
The ECA GMP WebApp is a free of charge service and can be opened by visiting app.gmp-compliance.org in any smartphone or tablet PC browser.
Guideline Manager Software Version 15.0.0
In addition to the new WebApp the ECA also continued to provide another version of its well-established GMP Guideline Manager Software. It is another exclusive service for attendees of ECA courses and conferences who receive the CD free of charge. This software comprises more than 1.100 GMP relevant Guidelines from FDA, EU, ICH, PIC/s, WHO and other organisations – however, only those guidelines that refer either to GMP topics or have an influence on GMP (e.g. Notice to Applicants). The guidelines are displayed in a well-structured Guideline Tree. Another very useful feature is the software’s comprehensive search engine, allowing users to either conduct a keyword search in the complete database or in certain categories, e.g. only in FDA documents (note: this feature is not available for the online version).
A "Guideline Tree" sorts regulations by issuing authorities, and a second "Guideline Tree" sorts them by topics. Users may use this Guideline Tree to find the applicable guideline, e.g. to “sterile manufacturing” or to “APIs”.
ECA Good Practice Guide as Version 14
In November the organization also published the 14th version of its respected Good Practice Guide "FDA cGMP, EC GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap". The revised Guide is a comprehensive juxtaposition containing the requirements laid down in FDA's cGMP Guide, the EU GMP Guide and ISO 9001. The updated Matrix now has 26 pages as well as further 500 pages for the three regulations
FDA cGMP Guide
EU GMP Guide Part I, II, and III incl. all Annexes
ISO 9001 Quality Management Systems
In addition, the Good Practice Guide contains an ISO 9001/ICH10 Matrix and the complete Part III to the EU GMP Guide.