ECA Foundation Annual Report 2018

ECA Academy

The ECA Academy as the ECA Foundation’s educational organisation conducts education courses – also as part of a GMP certification programme – conferences and webinars around GMP and regulatory compliance. The courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc. Conferences, on the other hand, rather put new trends and developments into the centre.

In 2018 more than 4.300 professionals from close to 70 countries attended the over 190 ECA courses, conferences and webinars and thus joined the organisation as members.

ECA Members

Further Growth in ECA Foundation’s Interest Groups

The European QP Association has been the voice of Qualified Persons and similar functions in the European pharmaceutical industry since its foundation in 2006. In 2018 the association continued to grow, counting more than 3.000 members from over 40 countries. The number of members rose from 2.500 members in the year before to over 2.700, that of associate members from 220 to 270.

European QP Association Members

European QP Association Associate Members

Throughout the year the EQPA again conducted a number of surveys. Results of these surveys are available to members of the association in the members’ area and the IMP Working Group’s download area.

The European Medicines Agency (EMA) asked industry associations throughout Europe to pass on some questions to their members to receive feedback with regard to the qualification of API manufacturers. The EQPA’s survey was conducted in January 2018. Altogether 245 members provided feedback. The results were summarised and sent to EMA end of January.

Further, the EMA updated their template for GMP non-compliance statements for manufacturers after inspections. One major driver was the intent to provide clarity and support in such matter to the QPs. The EQPA wanted to provide feedback to EMA on the basis of a few questions. Therefore a survey was conducted to evaluate the QPs’ expectations and needs. Altogether 77 colleagues provided their Feedback.

Another survey was supposed to get an overview about QP Liability and the possibilities for insurance. The results were summarized and also published in the members' area on the website.

Based on the evaluation forms of the IMP pre-Forum session, the presentation on On-demand packaging and Direct to Patient (D2P) shipments was well received and appreciated. Therefore the IMP Working Group invited members to complete a survey on D2P shipments.

End of April the European Medicines Agency (EMA) issued the draft of the Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. To forward consolidated comments, the IMP Working asked EQPA members for feedback. Comments were submitted in August.

The IMP Working Group also compiled a survey on the “order” as referenced in Annex 13 section 8 and in the Detailed Commission Guidelines section 5.2. From the group’s perspective the guidance does not provide the industry with clear instructions. Aim of the survey was to get a benchmark of current industry practice and to discuss this at the IMP QP Pre-conference in November.

Results of the survey asking respondents to describe approaches to the delegation of QP tasks according to Annex 16 sections 1.7.1 -1.7.21 and Annex 13 section 40 were also published in the download area of the IMP Working Group. A report on this survey was also part of the EQPANews December issue.

The EQPA was also very active in terms of communicating and meeting with authorities. For instance, it was invited to join an industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products. This meeting was conducted in March. Meeting notes were circulated through the board members who participated in the meeting personally and via remote. EMA was clear on the just "agreed" draft withdrawal agreement between EC and UK. This agreement will not prevent UK to become a third country starting from 30th March 2019. Any other arrangements finally ratified will only become final during Q1/2019 and therefore will come too late to be considered in the companies´ and EMA´s strategies. It was very clearly recommended to prepare on the scenario of a hard Brexit.

The EQPA Chairman also joined the EMA Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicinal products in September. The meeting also provided clarification to questions QPs might have, for example:

  • Only with a signed withdrawal agreement the transition agreement could be signed and become effective
  • without transition agreement full application of laws to a 3rd country
  • with transition agreement QP certification and testing arrangements could continue as before until end of transition period (31 December 2020)
  • GMP certificates are in general legally not necessary for QP certification if the QP has assessed the risk as satisfactory and is convinced of appropriate GMP. If GMP certificates issued by UK may become invalid the manufacturer and QP may have to re-assess the Situation.

Together with EFPIA and other industry associations, the EQPA Board forwarded a letter to EMA addressing the EMA announcement to cancel the EMA-IWG-IPM. This letter’s intent was to emphasize that stakeholders see the need for discussions to continue – irrespective of the cancellation of the IWG meeting with EMA and the continuity plans of EMA. In an answer to this letter, EQPA was invited to attend a telecon with EMA secretariat and other associations in January 2019 to discuss a status update.

Further activities of the EQPA comprised comments to authorities’ regulatory initiatives. For example, the EQPA Board forwarded their comments on the Revision of ‘Annex 1: Manufacture of Sterile Medicinal Products’ to EMA in early March. As mentioned before, the Association's IMP Group sent summarised comments to EMA on the draft of the Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice.

The EQPA also conducted several courses and conferences – among them the annual QP Forum, which was held for the 13th time; this time in Prague on 29/30 November with three pre-conference Sessions on the 28th. More than 250 participants and 30 speakers met to exchange experiences with colleagues and to establish contacts and networking possibilities.

In August, a joint ECA/EQPA conference was held in Chicago, USA. The objective was to share information and experience and to discuss the critical areas of European GMPs and the QP’s daily work.

The ECA Good Practice Guide No. 2 "Duties and Responsibilities for Qualified Persons in the EU" was amended and published on the EQPA Website. Version 4.0 now additionally comprises the new chapters Qualification and Validation as well as QP and RP Interface.

A new section of the website issued in December summarizes “Brexit”-related information relevant for QPs in a so called “Brexit Corner”.

Pharmaceutical Microbiology Group

The Pharmaceutical Microbiology Group has also been developing quite well since it was established. The group concentrating on all relevant microbiological questions in the context of the development and manufacturing of pharmaceutical, biopharmaceutical and combination products, counted almost 650 members from close to 60 countries by the end of the year.

Members in the ECA Pharmaceutical Microbiology Working Group

In 2018 the group worked on several publications. The board started to discuss a new Q&A paper on culture media. First results were presented later in the year. The paper turned out to be more comprehensive than initially intended, though. It was thus decided to spend more time on developing it further before publication. Moreover, the first chapter of the Guideline document on Deviation Handling of microbiological Environmental Monitoring Excursions in non-sterile Pharmaceutical Manufacturing was finalized and introduced at the European Microbiology Conference scheduled in April. It was also made available in the Group’s website members’ area. Moreover, the first chapter of an OOS/OOL Guide was completed.

In November the board met to discuss and initiate a new MAT Task Force. Members also discussed a joint PEI ECA Workshop there, which is supposed to take place in early 2019.

Analytical Quality Control Group

The Analytical Quality Control Group unites technical staff and management involved in routine Quality Control & R&D testing laboratories for APIs, Excipients, drug products as well as for herbals. End of 2018 it had more than 180 members from 36 nations.

Members of the ECA Analytical Quality Control Group

The group developed its new internet presence, which was launched in early 2018.

During 2018 the group’s board met twice: in April members defined and finalised their work plan 2018/2019 and discussed workshop materials for the PharmaLab Congress in Dusseldorf in November 2018. They also defined their stability testing activity with EFPIA there. In the November meeting the progress of the work plan 2018/2019 was reviewed, feedback to the APLM Guideline was collected to prepare for version 2, and it was followed up on the ICH Q2(R1) and USP <1220> progress. During this meeting the board also set up a strategy and structure for Sampling and Sample Management Guideline for 2019.

During the workshops at the Analytical Procedure Lifecycle Management (APLM) Conference end of November 2017 delegates had the opportunity to provide comments. These comments were incorporated to set up the first final version of the Laboratory Data Management Guidance about Analytical Procedure Lifecycle Management (APLM). This final version was distributed to a selected audience (FDA, USP, EFPIA, etc.). It was also launched officially at the PharmaLab Congress on 20 November 2018 in Düsseldorf/Neuss.

A survey about the awareness of the concept of the Analytical Procedure Lifecycle Management (APLM) Approach and the use and acceptance of Quality by Design for analytical methods was completed at the end of July. Feedback was provided by 86 persons. The results of this survey were also presented at the PharmaLab APLM Workshop on 20 November 2018.

Validation Group

The mission of the Validation Group is to assemble knowledge on Validation, for example by continuously developing ECA´s Process Validation Good Practice Guide. In 2018 the group established in 2011 grew from 560 active members in 2017 to close to 760, representing more than 60 countries.

Members of the ECA Validation Group

In regular tele conferences the group’s task force discussed draft 5 of its “Modern Qualification guide for fast track qualifications”. The final official draft was then launched at the “Modern Qualification Conference” in September. To better manage further updates, the Task Force was later split into the subgroups review team, 'red thread' team, equipment category team, process validation (PQ/PV) team and the conference team. The Guide was also distributed to a selected audience (FDA, USP, EFPIA, etc.). It is planned to summarize, address and implement feedback. The “official final” version is scheduled to be issued in September 2019 – at a 2nd Modern Qualification Conference.

In the 2nd quarter further events were conducted – among them Process Validation in the light of Annex 15 and FDA Requirements, Modern EU and FDA Validation: OPV/CPV from Control Strategy to PQR. Part of the various scheduled courses and conferences is a further course on Analytical Methods for Cleaning Validation planned in September 2019.

A survey on Modern Qualification was conducted in August 2018. The results were presented in the ECA´s newsletter (part I and part II) and at the Modern Qualification Conference.

European GDP Association

The European GDP Association aims at supporting the pharmaceutical industry, authorities and logistic providers with regard to the implementation of Good Distribution Practice. At the end of 2018 it counted close to 1.900 members from more than 60 countries.

Members of the Good Distribution Practice Association

In the first half of the year the GDP Interpretation Document was finalised and ready to be published as a printed version. This final GDP Guidance on Interpretation and Implementation was published jointly by the ECA Foundation and the Pharmaceutical Quality Group (PQG). The chapters are built around the format and text of the 2013 EU GDP guidelines, providing a sound basis for the implementation and maintenance of a GDP quality system with clear responsibilities and processes and the application of risk management principles. It should be of benefit to all involved in GDP activities for initial training, continuing professional development and as a reference source or audit tool. Free copies were available for participants of the GDP Conference in Barcelona in June. Altogether 76 delegates from 22 countries joined this conference.

PQG further prepared a PDF interactive format of the document and also forwarded a PDF version of the GDP Interpretation Document to the competent authorities.

The Japanese Pharmaceutical Manufacturers Association, JPMA, asked for permission to publish a Japanese version of the “Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline” in the periodical publications issued by JPMA. Accuracy of the translation was to be ensured by JPMA.

The Association’s Code of Practice for Responsible Persons (RPs) in GDP was further revised. Version 2 is now available in the members’ area of the European GDP Association website. A small task force developed the update to ensure this document continues to be a useful resource for those working in this sector. In particular, the changes include more information on the expectations of the role and responsibilities of a RP in line with increased regulatory agency focus on the RP. Additionally, there is further guidance on data integrity expectations and more details regarding different aspects of the role of RP where this can provide improved clarification of requirements and expectations.

Already started in the year before, the idea of a survey on GDP implementation was to find out what the current status of implementation with regard to Good Distribution Practices at wholesalers and pharmaceutical manufacturers is. Altogether 98 persons responded to the questions. The summarized results are available in the download section of the members’ area.

Toward the end of the year the Association started another project with PQG to create a guidance document for interpretation and implementation of the GDP requirements for APIs. Work started in November with the aim to have the new document published in November 2019. Format and structure of the document will be the same as the GDP for finished products. For this purpose a Joint Venture Agreement between the Pharmaceutical Quality Group (PQG) of the Chartered Quality Institute and the ECA Foundation was established to clarify the roles, responsibilities and accountabilities of both the PQG and ECA in the delivery of this guideline on Good Distribution Practices for APIs. The agreed intent is to make “The Guideline” available free of charge to members of ECA and PQG via the respective organisations’ websites. A professionally designed publication alike the interactive GDP Guidance on interpretation and implementation will possibly follow.

Visual Inspection Group

Assembling knowledge on the visual inspection of parenterals, for example by continuously developing the best practice paper, is the mission of the Visual Inspection Group. This group was founded in 2013 and now counts almost 1.900 members from 70 countries.

The core of the Visual Inspection Interest Group counts more than 250 members from 35 countries

As the Visual Inspection Group’s chairman, Tobias Posset, became official member of EDQM’s Expert Group 12 in 2017 – the group developing the chapters of the European Pharmacopeia on Visual Inspection and Container-/Closure Integrity testing of parenterals – ECA`s feedback was provided to EDQM in order to support the revision of Ph. Eur. 2.9.20 (including an appendix for explanation).

The board met in October before the ECA conference ‘Particles in Parenterals’. Among others, it was decided to work on an update of the group’s Best Practice Guidance on Visual Inspection and to publish it in the first quarter 2019. This updated version will comprise editorial changes and clarifications. A further update depends on the finalisation of the Annex 1.

ATMP Group

The 2017 established ATMP Group today comprises more than 150 members from 20 countries across Europe. Its objective is to provide a Europe-wide networking platform for persons involved in the development, manufacturing, quality management and marketing authorisation of Advanced Therapy Medicinal Products (ATMP) by facilitating effective and efficient communication between sciences, industry, competent authorities and the pharmacopoeias. It also wants to promote active discussion on the latest regulatory requirements for ATMP within the European Union, US and worldwide. It also intends to identify and address regulatory, scientific and technical issues and challenges, including training needs.

Members of the ATMP Group

Early in 2018 the latest of the ECA Foundation’s Interest Groups launched their website. In addition to the contents from the AGORA website it provides a number of guidelines. All AGORA members were addressed and invited to join the new group – almost 100 persons joined.

The new group’s board – also comprising two representatives from the Paul-Ehrlich-Institute, the German Federal Agency for Vaccines and Biomedicines – met end of June for the first time, just prior the first GMP for ATMPs Conference in Berlin, Germany. There the future orientation and the business plan 2018/2019 were discussed.

In a telephone conference end of July the respective conference in 2019 was discussed and a planned survey was finalised.

The Group was also represented at the stakeholder consultation meeting at the European Commission in Brussels in June regarding the revision of the blood directive (2002/98/EC) and the tissues and cells directive (2004/23/EC).

At PharmaLab 2018 (20/21 November in Düsseldorf/Neuss) an ATMP Session was conducted for the German speaking part. Further, planning for an expert industry/authority workshop as well as for a GMP for ATMP education course in 2019 were started.

Different provisions of the new European GMP guideline specific to ATMPs are discussed intensively among authorities, academia and industry involved in the development and production of ATMPs. Thus the group set up a survey to find out what the “hot topics” are for members of the ATMP Group. The survey was conducted from November through December. Results are supposed to be discussed in the next board Meeting.

IT Compliance Group

The IT Compliance Group’s goal is to support pharmaceutical industry in implementing new IT technologies. From 2017 to 2018 memberships increased from 320 to 388, with members coming from 50 countries. To reflect the broader scope of topics the group is covering, the group’s name was changed to Data Integrity & IT Compliance in 2018.

Members of the Data Imtegrity & IT Compliance Group

End of the first quarter the Data Integrity & IT Compliance together with the Analytical Quality Control Group issued version 2 of their “Data Integrity Guide”. This new version includes many practical examples for implementing data integrity – with the following scope:

  • Definition of data governance in the GMP area as a set of policies and procedures within a Pharmaceutical Quality Management System which leads to ensuring data integrity and data security within an ethical corporate culture
  • Providing a single source of clear and concise harmonised high-level guidance document covering data governance and data integrity with regard to corporate, laboratory, production and IT activities within the framework of a Pharmaceutical Quality Management System
  • Review and evaluation of regulatory requirements and guidelines to work towards global harmonisation and compliance
  • Providing a model framework to achieve objectives 1 through 3
  • Providing more detailed appendices for specific data integrity topics

Version 2.0 takes into account the requirements of the latest regulatory initiatives – e.g. documents published by MHRA, WHO, FDA and PIC/S.

Further, the group discussed several new projects – among them the development of a Data Integrity Toolbox as well as an e-compliance initiative. The first Tool Box documents were reviewed with board members later in the year.

A 2-days Data Integrity Conference was planned as part of the Pharma Congress 2019 – with 12 lectures – including presentations from three inspectors – focusing on manufacturing and Engineering.

The group (as part of the ECA Foundation) was invited by PIC/S to comment their draft of PI 041 on Data Integrity. ECA and members of the interest group organised a workshop on 19-20 February 2019 in Berlin to comment the document.

ECA Publications

All ECA Interest Groups have been working on guidance documents – with the goal to assist stakeholders in implementing the requirements in a harmonised and compliant manner. In 2018 the following documents were available:

European QP Association

  • ECA Good Practice Guide No. 2 "Duties, Responsibilities and Continuous Training for Qualified Persons in the EU" – Version 4.0

Pharmaceutical Microbiology Group

  • Guidance on Deviation Handling of microbiological Environmental Monitoring Excursions in non-sterile Pharmaceutical Manufacturing – Chapter 1

Analytical Quality Control Group

  • Analytical Procedure Lifecycle Management Guideline
  • ECA Standard Operating Procedure (SOP): Laboratory Data Management - Out of Specification (OOS) Results
  • Laboratory Data Management Guidance: Out of Expectation (OOE) and Out of Trend (OOT) Results

Validation Group

  • Modern Qualification – A guide to effective qualification based on customer-supplier relationship
  • ECA Good Practice Guide on Validation – Version 02

European GDP Association

  • ECA/PQG Guidance on the Interpretation and Implementation of European Good Distribution Practice
  • ECA Code of Practice for the Responsible Person for GDP

Visual Inspection Group

  • Good Practice Paper “Visual Inspection of Medicinal Products for Parenteral Use” – Version 3.0

Data Integrity & IT Compliance Group

  • ECA Audit Checklist - PaaS Service Providers
  • ECA Audit Checklist - SaaS Service Providers
  • ECA SOP - Selection Process for Cloud Service Providers
  • Data Integrity Guide – Version 2.0

Guideline Manager / ECA GMP WebApp

The comprehensive manager comprises more than 1.100 GMP relevant Guidelines from FDA, EU, ICH, PIC/s, WHO and other organisations – only those 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”.

The guideline 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 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 Matrix

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. Version 22 was released in July 2018 and comprises Annex 2 (in operation since 26 June 2018), Annex 17 (in operation since 26 December 2018) and a Template IMP Batch Certification (Part III supplement).

All publications issued by the ECA can be purchased on the ECA website (via Amazon).