ECA Foundation Annual Report 2014
Annual Review 2014
As the ECA Foundation’s educational organisation the ECA Academy mainly organises trainings – educations courses which are also part of a GMP certification programme, conferences and webinars – around GMP and regulatory compliance, picking up emerging GMP challenges and currently discussed subjects. While courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc., European conferences are organised as discussion forums on new trends and developments.
In 2014 the Academy conducted almost 130 courses, conferences and webinars with close to 3.000 professionals from more than 60 countries worldwide attending these events and thereby gaining a two-year membership in the Organisation.
In addition to memberships gained through attending any of the ECA Academy events, the organisation also offers individual memberships which are based on the calendar year and which do not require participation in any course, conference or webinar. The number of individuals signing up for these memberships slightly increased compared to the year before – to close to 40 from 18 countries.
Further, companies can also benefit by signing up for a “group rate” – basically making all employees of the company in that country eligible for benefits like rebates. In 2014 almost 10 companies (among them companies from Germany, Switzerland, Netherlands, Denmark, Norway, Mexico and Malaysia) signed up for this group rate.
ECA Foundation’s Interest Groups receive growing attention
In 2014 the European QP Association’s membership base increased again – and is now close to 2.000. Together with the associate memberships which also climbed to more than 300, the Association now has a total of roundabout 2.400 members and unites QPs and professionals working in similar functions from more than 40 countries. Among these members are also close to 800 QP concentrating on Investigational Medicinal Products (IMPs).
There were also some changes on the Association’s Advisory Board: on the industry side Dr Susanne Ding from Boehringer Ingelheim Pharma, Germany, joined – replacing Martine Tratsaert. She also took over her lead in the Association’s IMP Working Group that concentrates on the specific requirements with regard to IMPs. On the regulator’s side there also were two changes. In lieu of Ian Thrussell from the WHO Tor Gråberg from the Swedish Medical Products Agency was nominated as new member. Later in the year the board was also extended by another member. For this seat Dr Rainer Gnibl from the District Government of Upper Franconia, Germany, was appointed.
As in the years before the Association was also quite active in 2014. The two QP education courses – this time conducted in Vienna and Berlin – receive a constant attention. The QP meeting place, the annual QP Forum – once more including the IMP Group’s full day pre-conference, was also conducted in Vienna, Austria, and attracted more than 200 delegates from across Europe and beyond again. In addition the course conducted in New Jersey in June aimed – as in the years before – at educating American colleagues on the role of the QP in Europe.
The QP Association has been active since 2006 already and has since provided valuable input to regulatory developments. Due to this input and its voice representing European QPs the organisation has been invited to meetings throughout the last years. In the last year these meetings included a workshop on the revision of Annex 16 – Certification by a Qualified Person and Batch Release at EMA, participation in a Stakeholder's workshop on the delegated act on safety features for medicinal products for human use as well as participation in the annually conducted meeting of GMP/GDP Inspectors Working Group with Interested Parties. The Association also met with other industry organisations like APIC and EXCIPACT to explore activities all parties and specifically their members can possibly benefit from.
Towards the end of the year the Association also conducted another survey to find out how QPs are perceived in their work environment. More than 400 members provided input – a very high response rate, showing the tremendous interest in the issue.
Finally, other activities for the members included the compilation of a Q&A set concentrating on questions around how to become a QP, duties of the QP, its role in the supply chain, in contract manufacturing and with regard to APIs and starting materials as well as relative to IMPs. A “Tool Box for QPs” was developed and published with the goal to support them with materials like checklists, decision trees or workflows. In December the first version of the EQPA Newsletter was issued, another information service for the Association’s members.
The Rapid Microbiological Methods (RMM) Working Group also grew by about 5% to close to 450 members in 2014.
Due to changes in their careers, to professional re-orientation or due to retirement, four members retired from the Advisory Board and were replaced by new members.
To provide members with a better overview and with additional information the group reorganised its paper and publication list on the website.
An SOP or Guidance on OOS the group planned to develop was renamed as it will rather be a compendium of different microbial control strategies. It is supposed to be a document on how to perform the lab investigation for different microbial tests and other micro-specific topics – e.g. “What is a trend”. Board Members independently started to create a first chapter on the topic of sterility testing. The experienced members looked for their strategies/SOPs for lab investigation and already provided first information for discussion.
With regard to courses and conferences the group also conducted a number of events again – among them the two annual conferences European Microbiology Conference in Prague with close to 70 delegates and the combined Mycoplasma / RMM Conference in Heidelberg with more than 70 attendees. In addition a new Bioburden Workshop attracted 40 participants who graded the event very well.
The PharmaLab Congress which was conducted in November for the 2nd time also comprised the Endotoxin and Pyrogen Testing Conference for the first time. With speakers from FDA, EDQM and from the Paul-Ehrlich-Institute (PEI) the conferences was attended by more than 70 delegates.
Memberships in the ECA Analytical Quality Control Group slightly rose to 142 from more than 30 countries.
In 2014 version 2.1 of the group’s SOP on Out of Specification (OOS) Results became available as a final document. ECA members can download this version from the ECA members’ area for free.
Originally, the group had planned to also cover the handling of Out-of-Trend results (OOT) in its SOP. During the development phase of the OOS SOP it had showed, though, that the handling of Out of Expectation (OOE) and Out of Trend (OOT) results cannot be covered in the same document as the subjects OOE and OOT are much too complex to address all relevant aspects in one SOP. Therefore, the group planned the creation of a separate SOP on OOE and OOT. This SOP is supposed to have the following priorities and will thus be structured accordingly:
- Methods and approaches for detecting Out of Expectation (OOE) results within an analytical sequence which can be traced back to the process capability of the analytical procedure.
- Methods and approaches for detecting Out of Trend (OOT) results between analytical sequences where no trend would be expected – for example a variety of statistical process control approaches.
- Methods and approaches for detecting Out of Trend (OOT) results between analytical sequences where a trend can be expected – as is the case for stability testing.
A Draft OOE/OOT SOP was supposed to be launched at the OOT Forum in October 2014. However, the content still has to be reviewed due to the input coming from Forum participants. These participants will now exclusively obtain the draft for their review and comments. And the availability of the OOT SOP is now expected for the OOT Forum 2015.
Due to the “new” validation “Life Cycle Process” approach comprising the three stages “Process design”, “Process Qualification” and “Continued Process Verification” the Process Validation Group conducted a first time conference that covered issues around the 3rd stage. Under the leadership of one of the group members it wanted to provide impulses for the implementation of continued process verification in routine production and concentrated on the state of the art regarding systems for detecting unplanned departures from the process, the handling of the monitoring, the differences between Continued Process Verification (FDA) and Continuous Process Verification (EMA, ICH Q8) as well as possible parallels regarding Medical Devices and statistic parameters that could help.
The Good Distribution Practice Group was very active in 2014. Its main focus was on the continuation of the interpretation of the EU GDP Guideline. For this purpose the group had already started a project in co-operation with the Pharmaceutical Quality Group (PQG) in the UK in 2013. Under the leadership of ECA Advisory Board Member Dr. Afshin Hosseiny a lot of progress was made. In April 2014 the Working Group published an interpretation of chapter 7 on “Outsourcing”. The chapter is complemented by a quality agreement template which can be used to develop a contract for outsourced GDP services. In June 2014 a GDP supplier database was published in the members’ area of the group’s website. On 1st September 2014 the group published the interpretation of the EU GDP chapter 2 “Personnel”, and on 5th November the interpretation of EU GDP Chapter 5 “Operations” was released. As a result the number of members in GDP Group continues to increase. By end of 2014 the group counted 410 members from more than 20 countries. It is the goal of the group to finalize all remaining interpretation chapters to the EU GDP Guideline in 2015.
The Visual Inspection Group is the latest ECA Interest Group. It was founded in December 2013 by representatives of the pharmaceutical industry and GMP authorities and grew to more than 400 members in only two weeks.
The Group’s mission is to assemble knowledge on visual inspection of parenterals, for example by continuously developing the best practice paper on visual inspection.
The first version of the best practice paper was published during the ECA Conference “Particles in Parenterals and beyond” in Copenhagen in September 2014.
End of the year Dr. Tobias Posset, Head of Production Support, Roche Diagnostics Mannheim, was appointed chair of the group. Started as a Working Group it was also converted to an Interest Group in December, opening the Group for everybody interested.
The ECA GMP WebApp launched in 2013 received more and more attention from industry and from authorities as well. It 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.
In addition to the latest news the app also provides major GMP Guidelines from authorities worldwide. It also comprises 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 16.0
In 2014 the ECA also continued to provide its well-established GMP Guideline Manager Software. 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 16
The 16th 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 September.
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.