ECA Foundation Annual Report 2017

Annual Review 2017

ECA Academy
Professionals in the pharmaceutical industry have been relying on the ECA as advanced training and information services provider for more than 15 years.

In 2017 the number of professionals attending the ECA’s training programmes comprising close to 170 courses, conferences and webinars and thus becoming new members totalled up to close to 4.000 from almost 70 countries.

ECA Annual Review 2017 - ECA Membership development
ECA Members

ECA Foundation’s Interest Groups continue to grow

Founded in 2006, the European QP Association, the voice of Qualified Persons and similar functions in the European pharmaceutical industry, continued to grow in its 11th year as well. By the end of 2017 the organisation counted more than 2.700 members from over 40 countries – 2.500 professionals of them joined as members and over 220 were attributed the status associate members.

ECA Annual Review 2017 - EQPA members
European QP Association Members
ECA Annual Review 2017 - European QP Association Associate Members
European QP Association Associate Members

In 2017 the Association announced a few major changes in its Advisory Board: Richard Bonner, who has been chairing the organisation since 2012, officially stepped down as chairman and member of the board. Ulrich Kissel was officially nominated as his successor and became the new Chairman in December. Furthermore, Georg Göstl from Shire and David Cockburn (formerly with EMA) were officially nominated as new board members and also joined the board in December.

Throughout the year both the QP Association and its IMP Working Group again initiated many activities. At the EMA meeting in London, for instance, the EQPA was represented by Tor Graberg. His summary report of the meeting can be found in the members’ area on the website.

On behalf of the EQPA David Cockburn further participated in a webinar entitled “Brexit related manufacturing and supply". The objective of this webinar conducted by the EMA was to discuss with industry stakeholders (Human and Veterinary Industry) manufacturing and supply questions linked with Brexit preparedness activities consequences as a follow-up in particular to the 4th and 13th October 2017 industry stakeholder meetings, where this topic was identified as a priority. David provided a summary of the questions asked by the industry associations and answers provided by the EMA. These Q&As are also available in the download section in the members’ area.

The Good Practice Guide “Duties and Responsibilities for Qualified Persons in the EU” was first developed in 2006. It extracts the requirements QPs have to fulfil from the various relevant documents and summarizes them. However, as there are also responsibilities in their daily processes as well as requirements for continuous training that are not defined there in detail, the Guide also provides some guidance with recommendations. This Good Practice Guide was updated and is available as version 4.0 – also in the members’ area.

Moreover, in 2017 the EQPA also conducted several surveys again. The GMP/GDP IWG at EMA asked the European QP Association to support them in ascertaining the information required by QPs to allow release of medicinal products impacted by a statement of non-compliance. The EQPA therefore conducted a survey among its members, and more than 410 of them returned their feedback. Results are also available in the members’ area on the EQPA website.
Another survey wanted to find out what the current practice is of Manufacturing Authorisation Holders’ oversight of CMOs for batch release. It was intended to benchmark the practices across a number of pharmaceutical companies in relation to oversight of batches manufactured by Contract Manufacturing Organisations (CMO's) on behalf of Marketing Authorization Holders (MAH) - and specifically for those working within an organisation (MAH) that subcontracts manufacture and/or release of batches. The results of this survey were published as part of a Thesis for a Masters in Industrial Pharmaceutical Science. An article in the EQPA newsletter summarized the results. This (as all other) newsletters can also be downloaded from the members’ area.
Based on the QP tasks listed in Annex 16 sections 1.7.1 -1.7.21 and Annex 13 section 40, the IMP QP Working Group further developed a questionnaire on Delegation. The Task Force “to delegate or not to delegate” is led by Andreas Schwinn (Roche). The questionnaire was sent in December and tried to find out the current approach to the delegation of QP tasks 'as is'. Results are due in February 2018 and will also be published in the IMP Working Group’s members’ area.

Earlier in the year, the IMP Working Group sent in their comments on the Commission Delegated Regulation on GMP for IMPs to the EU Commission. As many other stakeholders, the Working Group recommended to implement the new regulations as much as possible into the existing GMP guidance. Thus, it would be easily possible to even add newly developed GMP Guidance, e.g. for ATMPs (both commercial and IMP) through another Annex. In its comments, the group gave clear examples how this could be achieved. The comments in detail are available on the EU Commission website.

The Association also conducted its annual meeting again – this time the 12th QP Forum was held in Budapest, Hungary – and it was a great success. More than 250 participants and 29 speakers met over three days to discuss QP relevant topics. The ratings of the various parts were very good.

With Bernd Renger and Dick Bonner, two very experienced and honored speakers of the well established QP Education Course announced their retirement from the speakers’ team – entailing some major changes in the program. Further, the IMP session was moved to a pre-course session which will be conducted in 2018 for the first time. The revision of the QP Education Course also comprises a workshop on OOS/OOT and a presentation on Elemental Impurities replacing the lab workshop offered so far.

Further activities included input for an article in the PinkSheet on the revised guidance issued by the CMDh on QP Declarations. Also, the IMP Working Group within the EQPA started a dedicated ATMP Task Force. This new Task Force will support a new ECA ATMP Interest Group. The planning for this new group started in 2017.

The Pharmaceutical Microbiology Group, concentrating on all relevant microbiological questions in the context of the development and manufacturing of pharmaceutical, biopharmaceutical and combination products, also continued to develop very positively. In 2017 it crossed the 500 members mark, counting 525 members at the end of the year.

ECA Annual Review 2017 - Pharmaceutical Microbiology Working Group
Members in the ECA Pharmaceutical Microbiology Working Group

Early in the year the group finalized their OOS Guidance’s first chapter entitled “Deviation handling of microbiological environmental monitoring excursions in non-sterile pharmaceutical manufacturing” – which was first passed on to the Board for commenting. The revised document was then shared with the members, and first comments were received in the second half of the year. It was also reviewed by some external experts, and by the end of the year the chapter was ready and will be released at the European Microbiology Conference in April 2018.

Members of the Board further gathered information on common requests and problems with culture media. The goal was to group these issues and formulate 2-3 questions with their responses (until end of January 2018). The group will then review this draft (until end of February 2018). Until end of March 2018 a revised version is supposed to be published. This will be a living document and further issues/question will be added in the future.

Moreover, the group performed a brainstorming on the strengths and weaknesses, and partially on the opportunities and threats. This SWOT analysis is then supposed to be further developed to identify a maximum of four topics as a proposal for an action plan for the future direction/topics of the group. It is planned to be ready by early 2018, and the group announced feedback on this proposal until end of February 2018.

In May the group conducted the European Microbiology Conference, this time also comprising a workshop on bioburden. Further, in fall the PharmaLab Congress also comprised a Pharmacopoieal Update Session with two USP Experts, one EDQM Expert and two Industrial Members of the USP Expert Groups and the Swiss Representative of the EP Microbiology Expert Group as Moderator. .

With its Analytical Quality Control Group the ECA wants to address technical staff and management involved in routine Quality Control & R&D testing laboratories for APIs, Excipients, drug products as well as for herbals. It unites 140 members from 30 countries.

ECA Annual Review 2017 - Analytical Quality Control Group
Members of the ECA Analytical Quality Control Group

After the group’s two SOP documents on OOS results as well as on OOE and OOT results were published in the members’ area of the ECA website, the board decided in a board meeting to start with another guideline draft on Analytical Procedures Lifecycle Management (APLM). It was launched at the Analytical Procedure Life Cycle Conference in November, which also provided the opportunity to discuss the draft and gather industry input in a workshop environment. This conference also discussed the ICH Q2 revision process and USP activities on General Chapter <1220>.

In addition, the group further developed its new internet presence, supposed to be launched in early 2018.

The Validation Group was founded in fall 2011 by representatives of the pharmaceutical industry after ECA´s 4th European GMP Conference. The mission of the group is to assemble knowledge on Validation, for example by continuously developing ECA´s Process Validation Good Practice Guide.In 2017 it grew to 560 active members.

ECA Annual Review 2017 - Validation Group
Members of the ECA Validation Group

The group set up a Qualification and Validation Task Force with the goal to develop qualification templates which are useful for suppliers and the pharmaceutical industry. It got together for a start up meeting end of March. At a later meeting six sections were identified which should be handled in an ECA Good Practice Guide “Modern Qualification guide for fast track qualifications”. One of the guide’s sections a group of suppliers was working on is supposed to concentrate on ”Qualifcation phases in a timeline” and to include a high-level model. By the end of the year the Good Practice Guide was distributed internally in the group in its 4th version for review. The final guide draft will be published at a new ECA Modern Qualification Conference, which is scheduled to take place in the 3rd quarter 2018.

In May/June the group conducted a validation session as part of the 7th European GMP Conference. The conference was attended by close to 170 professionals from across Europe and beyond. Delegates rated the entire event with a 2.0 (1 being excellent, 6 being failed). Other courses/conferences comprised Cleaning Validation, Statistical Process Control, Process Validation (2x), Ongoing Process Verification and a Validation Manager Course.

By the end of 2017 the European GDP Association – aiming to support the pharmaceutical industry, authorities and logistic providers with regard to the implementation of Good Distribution Practice – counted close to 2.200 members from almost 80 countries.

ECA Annual Review 2017 - Good Distribution Practice Association
Members of the Good Distribution Practice Association

In the course of the year the Association’s board announced some changes: Dr Laura Ribeiro, who is a Responsible Person at ID Logistics (formerly Logiters) in Portugal, has accepted her nomination as the fifth member of the GDP Association's Board. Another new member representing the global pharma industry is Saddam Huq who is Global QA Senior Manager Quality for Distribution & Cold Chain Management Vaccines, Quality Assurance Shared Services at GlaxoSmithKline, U.K. Before that Saddam Huq was Cold Chain Technology Head at Pfizer. On the authority side the Advisory Board also nominated a new member: Emil Schwan accepted the invitation to join. He is Pharmaceutical Inspector at the Drug Inspectorate of the Swedish MPA and a member of the PIC/S Working Group on GDP.

In cooperation with the PQG the GDP Association published the joint GDP Guidance document in a final version. This document is available in the members’ area of the GDPA website. Further, a new set of Questions & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline were also published there.

There are a number of detailed WHO Guidelines on Storage and Transportation. A lot of "supplements" have been published in May 2015. These 16 supplements cover a lot of relevant topics from a design of storage facility to transport route profiling qualification etc. However these guidelines and supplements are not easy to find on WHO's websites. The European GDP Association thus put together all these documents to provide a better overview and easier access. It can be found on the GDP Guidelines site.

In October Wolfgang Schmitt, Administration Manager of the Association, gave a presentation at the Cold Chain Forum in Seoul, South Korea, on behalf of the board. It was hosted by the Korea Conformity Laboratories (KCL) and the Korea Food Cold Chain Association (KFCA) and supported by the Korea Ministry of Trade, Industry and Energy and some other Associations. The aim of the presentation was to introduce European GDP Guidelines and the work of the European GDP Association. The delegates but also the organisers were impressed by the work and the support of the GDP Association to its stakeholders.

What is actually the current status of implementation with regard to Good Distribution Practices at wholesalers and pharmaceutical manufacturers? To find that out, the European GDP Association set up a survey among its members. Results are supposed to be published in the members’ area of the website in February 2018.

The Visual Inspection Group was founded in 2013 – with the mission to assemble knowledge on visual inspection of parenterals for example by continuously developing the best practice paper on visual inspection. It counted almost 1.700 members by the end of 2017 – representing more than 60 countries..

ECA Annual Review 2017 - Visual Inspection Group
The core of the Visual Inspection Interest Group counts more than 250 members from 35 countries

In 2017 the group’s chairman, Dr Tobias Posset became an official member of EDQM’s Expert Group 12 (Dosage Forms & Methods). This Expert Group is responsible for developing the chapters of the European Pharmacopeia on Visual Inspection and Container-/Closure Integrity testing of parenterals. There the revision of the Ph. Eur. 2.9.20 (including an appendix for explanation) was started – and the ECA feedback has been included within the new Pharmacopeia wording.

In the duration of the year the group finalized work on its position paper concerning container-/closure-integrity testing of sterile containers. Information was sent to all members. The paper is available in the download section of the group’s webpage.

The ECA Good Practice Guide “Visual Inspection of Medicinal Products for Parenteral Use" available in the members’ area as well, was forwarded to PIC/S for informational purposes.

The group meeting took place as part of the Conference “Control of Parenterals” which was conducted in October in Vienna, Austria – with great success. In total around 100 participants came to Vienna to one of the three conferences.

The IT Compliance Group was founded in 2014. Its goal is to support pharmaceutical industry in implementing new IT technologies. End of 2017 it had more than 320 members coming from close to 50 countries.

In 2016 the group had 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” has already been published and is available in the ECA website’s members’ area. In 2017 version 2 was in progress which is supposed to be issued in early 2018.

Besides that, the group started to evaluate the subject IT security and potential documents on this subject.

ECA Annual Review 2017 - IT Compliance Group
Members of the IT Compliance Group

ECA Publications

Guideline Manager Software / ECA GMP WebApp
Until 2017 the ECA published an annually revised version of the GMP Guideline Manager Software. This free of charge exclusive software for ECA members contains more than 1.100 GMP relevant Guidelines from FDA, EU, ICH, PIC/s, WHO and other organisations. The software comprises 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 – either sorted by the issuing authorities or by topics. Users may use this Guideline Tree to find the applicable guideline, e.g. to “sterile manufacturing” or to “APIs”.

As many PCs and laptops do not have CD ROM drives any more, the ECA decided to discontinue the GMP Guideline Manager on CD from 2017 on. Instead the database is available online and via the GMP WebApp in which users can log in using their ECA membership login. 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. It 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.

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.

ECA Good Practice Guide – The GMP Matrix9
This Good Practice Guide has been established years ago. It is a simple and clear juxtaposition of the requirements laid down in the EU GMP Guide, FDA's cGMP Guide and ISO 9001. It shows the requirements laid down for a given topic (such as cleaning or monitoring) in the respective regulation. Despite the size of this reference book it is nevertheless composed in such a way it can easily be taken along for audits. That's why an ever increasing number of companies provide their auditors and quality assurance department personnel with the GMP Matrix. In 2017 version 19 was reviewed, and version 20 is supposed to be released in early 2018.

Further publications issued by the ECA can be purchased on the ECA website.