ECA Foundation Annual Report 2015
Annual Review 2015
The ECA Academy has been organising and conducting trainings (educations courses, conferences and webinars) in the GMP and regulatory compliance environment since 1999. In courses and webinars pharmaceutical industry professionals in production, quality control, quality assurance etc. benefit from a continuous education. Conferences provide discussion forums on new trends and developments.
In 2015 the Academy conducted more than 140 courses, conferences and webinars. By the end of the year it counted more than 3.500 professionals from almost 70 countries worldwide as members. This is a 16% increase in participants compared to 2014.
ECA Foundation’s Interest Groups continue to grow
The European QP Association was established in 2006 and has been growing since. In 2015 the Association gained new members again – and today represents close to 2.200 QPs. Together with the associate memberships of close to 300, the Association now has a total of roundabout 2.500 members and unites QPs and professionals working in similar functions from more than 40 countries. Among these members are also more than 800 QP from the area of Investigational Medicinal Products (IMPs).
In 2015 there was only one change in the Association’s Advisory Board: Tor Gråberg from the Swedish Medical Products Agency who had joined the board in the previous year, left the agency and is now Head of External Advocacy (Global Quality) with AstraZeneca. Hence the authority side is now only represented by two in addition to now five industry representatives.
The year was also marked by various activities. The two QP education courses conducted in Barcelona, Spain, and Munich, Germany, attracted close to 90 attendees. The annual QP Forum which has been including the IMP Group’s full day pre-conference for a number of years already was conducted in Berlin, Germany, this time and attracted again more than 200 delegates from across Europe and beyond.
One of the QP Association’s goals is to provide valuable input to regulatory developments – most frequently gained through surveys among the members. This effort is appreciated by the authorities and has lead to various meeting invitations throughout the last years, as the Annual Meeting of GMP/GDP Inspectors Working Group with Interested Parties in November in the EMA offices in London.
The Association also conducted a number of surveys throughout the year. To learn more about the industry’s management of excipient suppliers it collected input in the period between March and July. More than 160 respondents participated in this survey. Further, to provide consolidated feedback to the concept paper on a new Annex 21 issued in May, the EQPA asked members for their opinion between July and August. The survey was sent out to about 1.800 persons. Altogether 248 members completed the survey – which is a response rate of almost 14 %. Another survey conducted among the members of the IMP Working Group on investigator sponsored studies also resulted in more than 100 responses which were discussed in detail during the QP Forum IMP Pre-Conference.
Finally, the EQPANews issued end of 2014 for the first time was continued with two further editions in 2015 – and will also be continued in 2016 as an additional service on a regular basis (twice a year).
By the end of 2015 the Rapid Microbiological Methods (RMM) Working Group counted close to 450 members.
A change in the Paul-Ehrlich-Institut (PEI), the German Federal Institute for Vaccines and Biomedicines, also entailed a change in the Advisory Board of the RMM Group: Dr Isabelle Bekeredjian-Ding joined the PEI beginning of 2015. Amongst other responsibilities, she also took over Thomas Montag’s position tentatively – and also followed him in the Board of the RMM Group. Sven Deutschmann and Axel Schroeder met her personally at the PEI to discuss subject-related issues and to re-initiate the planning of future joint events.
Further, the Board decided to advance the group in a new direction to cover other subjects in addition to microbiological rapid methods. To prepare the group for this impending change, a list with the existing expertise of the board members was put together to find out the subject areas in which further expertise is needed.
Also, in November the group established the new position deputy chair and nominated Marcel Goverde for this new position.
The group also conducted several events in 2015. The annual European Microbiology Conference in Prague was attended by more than 50 delegates. The PharmaLab Congress which was conducted in November for the 3rd time also comprised again the Endotoxin and Pyrogen Testing Conference and the Rapid Microbiological Methods Conference as well as the conference Adventitious Agents for the first time. With speakers from FDA, EDQM, from the Paul-Ehrlich-Institut (PEI) the PharmaLab conferences on the two days were attended by close to 300 delegates. Further, in addition to the annual education courses like Contamination Control and Microbiology for Non Microbiologist a new lab course on the subject Low Endotoxin Recovery was conducted in the labs of Microcoat. For 2016 the concept of the existing course „Microbiological Best Laboratory Practices“ was completely revised.
Memberships in the ECA Analytical Quality Control Group slightly rose to 142 from more than 30 countries.
As there is both a lack of knowledge in the industry and a lack of guidance for trend analysis from the regulators in spite of increased regulatory interest in this area, the group had decided to develop a separate guideline SOP to address the handling of OOT and OOE.
The group’s goal was thus to have a basic global framework for OOT/OOE within R&D, production and QC laboratories which would be acceptable for the authorities and adaptable for individual companies.
At the ECA OOT Forum 2015 in Barcelona, Spain, in December, version 1 of that guideline was presented. Participants had the opportunity to review and discuss the contents and technical aspects of the guidance document as well as looking at the scope and application of the proposed methods within industry. This new document aims at QC and other quality groups to encourage the application of a consistent and scientifically sound approach to trend analysis as part of a QMS for assuring data integrity.
Version 1 of the SOP consists of three core components:
- Recommended approaches for detecting out of expectation (OOE) data within an analytical sequence which are based on the known process capability of the analytical procedure used.
- Recommended approaches to detecting out of trend (OOT) data between analytical sequences where no trend is expected. These are based on standard Statistical Process Control methodology and
- Recommended approaches for detecting out of trend (OOT) data between analytical sequences where a trend is expected as is the case for Stability Testing.
The first Version of this “SOP” consisted of around 70 pages including appendices and examples. It was thus decided that the term “SOP” does not fit to such a comprehensive document. It’s now called “Laboratory Data Management Guidance” for OOE and OOT Results.
Activities of the Validation Group revolved around the final version of the EU GMP Guide Annex 15 (Qualification and Validation) revision which had been published early in the year and finally became effective on 1st October 2015. As there is an abundance of new requirements, the group wanted to know how industry will handle these new requirements – and thus set up a survey, which was completed by close to 60 colleagues.
The industry input was implemented in the group’s revision of the 1st version of the Validation Good Practice Guide. This revised version was then presented at the ECA’s 6th European GMP Conference in June in Heidelberg. The input gained there was implemented again.
Process Validation in the light of the revision of the Annex 15 and FDA requirements was also in the centre of attention of three events: a course offered twice in October attracted 60 participants. In addition, the Annex 15 conference in November drew more than 40 attendees. There the group finally published the 2nd version of the ECA Process Validation Guide.
In 2015 the group also started its new web presence – which is supposed to go live within the next few weeks.
The EU GDP Guideline defines a number of new requirements. To facilitate the implementation into practice the Good Distribution Practice Group had started its co-operation with the Pharmaceutical Quality Group (PQG) in the UK in 2013 already. While the group had 410 members from more than 20 countries end of 2014, this number has more than doubled since: today the group unites more than 1.000 members representing almost 70 countries.
In 2015 the group mainly focussed again on the interpretation of the EU GDP Guideline. Early in 2015 it issued its interpretation of the EU GDP chapter 5 “Operations, which was followed by the interpretation of chapter 6 “Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls” mid of the year.
Founded in December 2013 the Visual Inspection Group showed another significant increase in memberships in 2015 and now counts close to 1.000 members from almost 60 countries around the globe.
In 2015 the group appointed Dr Martin Becker from Hameln pharmaceuticals, Germany, and Al Goodwin, Amgen, Ireland, as new Advisory Board members.
The first version of the group’s best practice paper was published during the ECA Conference “Particles in Parenterals and beyond” in September 2014. Since then the group revised the paper and issued version 2 at the 2015 conference “Particles in Parenterals” in September – which attracted more than 80 delegates.
The latest Interest Group founded is theIT Compliance Group. Set up in 2014 already with the goal to support pharmaceutical industry to implement new IT technologies with regard to international GMP requirements it started activities in 2015. These activities included the launch of its new website as well as three draft documents on Cloud Computing which could be commented by the group’s members. This Interest Group will also possibly co-operate with the ECA Analytical Quality Control Group to cover the subject data integrity.
Today the IT Compliance Group has already 160 members coming from more than 30 countries.
Various authorities were provided with access to the ECA GMP WebApp launched in 2013. This app runs on all smartphones and tablet PCs (Apple and Android platforms) and allows users to have GMP information at hand any time and anywhere. With the login that can also be used for the ECA members’ area on the website it allows to access the worldwide most important GMP Guidelines from EU/EMA, FDA, ICH, PIC/S, APIC, IPEC and WHO in two webtrees – either sorted by the issuing authorities or by GMP topics.
In addition the app comprises the latest GMP news, ECA courses and conferences as well as a comfortable GMP Search function. This function can be used to search simply all ECA databases, just guidelines or course and conference materials.
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. Due to its set-up as web app users don’t have to download updates – as soon as new information is available on ECA’s website the app is also automatically updated.
Guideline Manager Software Version 16.0
The GMP Guideline Manager Software is a well-established tool. Attendees of ECA courses and conferences receive the CD with more than 1.100 GMP relevant Guidelines from FDA, EU, ICH, PIC/s, WHO and other organisations free of charge.
The guidelines are displayed in a well-structured Guideline Tree and can also be searched by 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 – Version 18
The 18th version of its respected Good Practice Guide "FDA cGMP, EC GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap" was issued in April 2015. 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 new version comprises Annex 15, two Guidelines added to Part III and the revised GMP/DIN ISO 9001 Matrix - based upon to the new Chapters 3, 5, 6 and 8.
Further publications issued by the ECA can be purchased on the ECA website.