ECA Foundation Annual Report 2016
Annual Review 2016
Professionals in pharmaceutical industry production, quality control, quality assurance etc. have been benefitting from the ECA Academy’s advanced training programmes comprising educations courses, conferences and webinars since 1999. While education courses provide continuous education, conferences can be seen as discussion forums on new trends and developments.
In 2016 the Academy conducted more than 100 courses, conferences and webinars. By the end of the year it counted more than 4.000 professionals (compared to 3.500 in the year before) from almost 70 countries worldwide as members.
In 2016 the ECA Foundation also announced the members of its Independent Authority Board (IAB) which had been established the year before in addition to the Executive Board and an Extended Board. This new board comprises authority representatives rather as an Advisory Committee to avoid any potential conflict of interest for its members. They are not involved in any of the ECA activities, and they are not part of the Foundation’s legal structure. This setup therefore now allows individual authority representatives to personally decide to get involved in discussions on a case by case basis. It also enables them to remain independent with regard to any ECA publication, comment or position paper – e.g. when the ECA is commenting on new regulations or when the ECA is publishing Best Practice Papers.
ECA Foundation’s Interest Groups continue to grow
The Established in 2006 the European QP Association represents the Qualified Persons and similar functions within Europe’s pharmaceutical industry. Today the Association has in total close to 2.500 members. It unites professionals from more than 40 countries. Among these members are also more than 1.000 QPs from the area of Investigational Medicinal Products (IMPs).
In 2016 the Association announced only one change with regard to its Advisory Board: Replacing Edit Szocs on the authority side was Mag. Pharm. Andreas Kraßnigg from the AGES, the Austrian Agency for Health and Food Safety. E.Szocs had left the agency end of 2015 and had thus also resigned from her appointment in the EQPA. Another change was announced in the QP Association’s IMP Working Group’s leadership team. Brenda Van Assche from Janssen succeeded Geneviève Meeus.
Both QP Association and its IMP Working Group were quite active in 2016 again. In June the IMP Working Group met in Brussels. This meeting’s main focus was on interaction with regulatory authorities and recent guidance issued for comments, an update from the QP to QP agreement task force and an intensive discussion around the set-up for the IMP Pre-conference and IMP parallel session for the QP Forum 2016 in Madrid.
A survey “The complexity and challenges of the management of global product release scenarios” was conducted to understand whether contract givers are completely mirroring the PQS of the contract receiver. This survey was developed together with Deirdre Dunne, a student studying at Trinity College in Dublin, Ireland for an MSc in Pharmaceutical Manufacturing Technology (the QP Course). Altogether 361 members responded. Deirdre Dunne evaluated the outcome and provided a summary which was published in the December issue of the EQPA news (No 5) and was also made available in the members' area on the website.
As the Brexit will also have implications for the QP's function the group published a statement “What does Brexit mean for the QP?” prepared by the lead-team in July.
As in the last years, the EQPA was also invited to the Annual Meeting of GMP/GDP Inspectors Working Group with Interested Parties in the EMA offices in London again. This meeting is annually conducted in fall. This time the organisation was represented by Dr Afshin Hosseiny, and his summary of the meeting can be downloaded from the members’ area on the website.
The EQPA also conducted its two QP education courses – this time in May in Budapest, Hungary and in October in Hamburg, Germany. Together the two events attracted more than 110 attendees. The QP Forum as the annual meeting and networking event for QPs in Europe was conducted in Madrid, Spain. It has been including the IMP Group’s full day pre-conference for a number of years already. Last year it attracted once again more than 250 delegates from across Europe and beyond.
Finally, started in 2014 as an additional service for its members the EQPA issued No 4 and 5 of its EQPANews.
Originally established as Rapid Microbiological Methods (RMM) Working Group in June 2006 at the Paul-Ehrlich-Institut (PEI) – the German Federal Agency for Vaccines and Biomedicines – the group gave itself a new direction in 2016. As members as well as authorities increasingly contacted the industry-wide well-known group with microbiological topics and questions beyond the scope it had originally defined for itself, the ECA and the Group Advisory Board decided to rename it to Pharmaceutical Microbiology Working Group and to extend its scope and activities. End of last year this group counted close to 480 members from more than 50 countries.
The new direction of the group also entailed the establishment of a new website which was issued end of July. Furthermore, the literature and publication lists were revised completely and now relate to the new covered topics of the group. The lists are available in the members’ area on the website. For its 10th anniversary of the group foundation meeting at the PEI in 2006 it further organised a joint workshop with the German Paul-Ehrlich-Institute in September 2016. This meeting attracted more than 50 professionals. Other courses and conferences organised by the group also comprised the European Microbiology Conference (together with a workshop on Biological Indicators) and a Modern Microbiology Lab Course. PharmaLab was conducted for the 4th time – again with conferences on two days with close to 300 delegates. The group’s annual meeting was also held during the two days event.
Memberships in the ECA Analytical Quality Control Group remained at 140 from more than 30 countries.
In 2016 the group started its second project: the development of a Laboratory Data Management Guidance Document for handling Out of Expectation (OOE) and Out of Trend (OOT) Results. Version 01 of this OOE/OOT Guidance Management Document was presented during the ECA Education Course Handling OOE and OOT Results in November in Prague, Czech Republic. The presentation of the basic proposals with regard to the mentioned subjects was followed by discussions and interactive workshops. This allowed participants to become familiar with the implementation.
The OOE/OOT education course was further followed by the ECA Post-Conference-OOS-Workshop. This workshop concentrated on the (European and US) authorities' expectations relative to OOS as well as on the ECA Analytical QC Working Group's OOS SOP Version 2. In this new version some updates (new calcuations for some of the equations) were implemented.
Both the SOP on OOS Results as well as the Laboratory Data Management Guidance Out of Expectation (OOE) and Out of Trend (OOT) Results are available as PDFs in the members’ area on the ECA website.
In late 2016, it was decided that the original working group was to be upgraded to a full interest Group and a new AQC Group Board was appointed. The first full board meeting will take place in Barcelona in April 2017 during the Valid Analytical Test Procedures course. Work has commenced on a 3rd guideline on the topic of Analytical Procedure Lifecycle Management which is intended as input to the ICH Q2 revision process due to start in Q3 2017.
In addition, there has been active liaison with and support for the USP Validation and Verification Panel’s development of a new general chapter <1220> on this topic. It is hoped that this ECA AQC guideline will be available in at least draft form by end of Q4 2017. In addition, the AQC Group joined forces with the IT Group in 2016 to generate a Guidance Document entitled “Data Governance and Data Integrity for GMP Regulated Facilities”.
As these are exciting new developments we hope that more interest will be generated and more ECA members will form part of the Group. The AQCG webpage is currently being updated and hopefully will encourage Membership.
Throughout the year the Validation Group grew to close to 380 active members from over 50 countries.
In July the Group asked its members about their topics of interest and in which direction they think the group should develop. In total, 84 participants answered. The results showed that the interest frontrunner is Process Validation, followed by Cleaning Validation and Requalification on third place. It was interesting to note a still high medium interest for the qualification of delivery systems. The results were published in the ECA Newsletter in November.
The Good Distribution Practice Group was founded in March 2013 – then as an Interest Group. In November it was transferred to an Association and today counts over 1.000 members from almost 70 countries. A new Board was formed under the leadership of Dr Afshin Hosseiny. Besides him Martin Egger, Pharmserv, Christian Grothe-Westrick, B.Braun Avitum and Sue Mann are involved. From the authority side Johanna Linnolahti from the Finish Inspectorate supports the group.
In 2016 the Group finalized its GDP Interpretation Guide it had started in cooperation with the UK based Pharmaceutical Quality Group (PQG) in 2013 already. All chapters are available for the members in the members’ area of the completely new website.
It further developed a Code of Practice for RPs (very similar in the structure to the Code of Conduct for QPs). The current version is also available in the website's members' area.
A GDP Conference was set up for 2017. This conference will be repeated in 2018 again and after that every two years.
Established in 2013 the Visual Inspection Group reached a new record in group memberships in 2016: more than 1.400 in total representing close to 70 countries.
In February the Group had asked members to provide their questions of interest – with the purpose to develop a new Q&A Document with frequently asked questions. These questions where compiled, evaluated and answered by the Board Members. The new Q&A Document was then made available for download on the website in September.
Further, version 3 of the Best Practice Guide on visual inspection was finalized and also presented during the two-days Particles Conference in September in Barcelona, Spain. This meeting drew more than 100 attendees and also comprised the Group’s Board Meeting. The revised Guidance document is also available on the website for the whole group. Now the group is working on a position paper regarding the container-/closure-integrity testing of sterile containers. It is planned to present the paper at the group meeting in October 2017 in Vienna at the latest.
The ECA’s IT Compliance Group was founded in 2014 with the goal to support pharmaceutical industry in implementing new IT technologies. By today it has over 260 members.
In 2016 it finalized its Best Practice Papers on Cloud Computing (SOP / Audit questions). Additional papers on Cloud Computing are still in discussion.
The Group further joined forces with the AQC Group to start a cooperation – the Data Integrity Task Force. Its first Guidance Document entitled “Data Governance and Data Integrity for GMP Regulated Facilities” was published in September and is available in the members’ area of the ECA website.
Guideline Manager Software Version 18.0 1
How do you access thousands of pages of GMP Guidelines from FDA, EMA, ICH, PIC/S, ICH, WHO and many other organisations worldwide? You could print them. Or purchase hundreds of booklets. But, apart from the huge amount of paper this would generate, how would you sort them to find a specific regulatory requirement in this comprehensive library?
To provide a comfortable solution the ECA Academy set up the largest GMP Guideline Database of its kind worldwide – and issued version 18.0 of the GMP Guideline Manager Software in 2016. This software structures the Guidelines in two so called "Guideline Trees".
1. Guideline Tree structured according to the issuing authorities (e.g. EU, FDA, ICH)
2. Guideline Tree structured according to GMP topics (e.g. GMP for Medicinal Products, GMP for APIs, sterile production, validation etc)
The GMP Guideline Manager can not be purchased – it is only available for ECA Members. And everyone participating in any of the ECA conferences or courses becomes member of the ECA free of charge for 2 years – and will have access to the database. This service is unique and not offered by any other organisation.
The GMP Guideline Manager can be accessed via the Members Area of the ECA Academy Webpage at www.gmp-compliance.org or via the ECA WebApp.
The ECA GMP WebApp was launched in 2013. It provides another comfortable way to get to the Guidelines issued by authorities worldwide. With the app ECA members have the same Guidelines database at hand as in the members’ area on the website – providing the thousands of pages of GMP Guidelines from EU/EMA, FDA, ICH, PIC/S, APIC, IPEC and WHO. They can be accessed with the login used for the members’ area on the website and are also available in the two webtree views – either sorted by the issuing authorities or by GMP topics.
The app further comprises the latest GMP news, ECA courses and conferences as well as a comfortable GMP Search function, allowing to simply search all ECA databases, just guidelines or course and conference materials. These functions are available for everybody – not only ECA members. They also have access to the major GMP Guidelines, a “light” version of the Guidelines database.
The ECA GMP WebApp is a free of charge service and can be opened by visiting app.gmp-compliance.org on any smartphone or tablet PC browser (Apple and Android platforms). 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.
ECA Good Practice Guide – GMP Matrix; Version 19
In March the 19th 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. The new version of this comprehensive juxtaposition of FDA's cGMP Guide, the EU GMP Guide and ISO 9001 comprises the revised GMP/DIN ISO 9001 Matrix – based on the new DIN EN ISO 9001-2015, the revised ICH Q10 / ISO 9001:2015 Matrix, the New Annex 16, effective since 15 April 2016 and the new DIN EN ISO 9001:2015.
Further publications issued by the ECA can be purchased on the ECA website.
1 As many PCs and laptops do not have CD ROM drives any more, there will be no GMP Guideline Manager on CD from 2017 on. The database will still be updated regularly, though, and is available online and via the GMP WebApp.