ECA Foundation News
To get an idea about what the ECA Foundation and its various groups have been working on or have accomplished recently, please see the latest news.
8 March 2023
ECA publishes New Guide on GMP Compliant Equipment Design
The purpose of the ECA's GMP Equipment Design Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made. To this end, the guidance contains numerous references and points of contact, a sort of a road map, that offers detailed information on the requirements or ways of proceeding for individual cases. Read more about the Guide here.
22 February 2023
Expert Working Group submits Comments to the Concept Paper on the revision of EU / PIC/S Annex 11
In November 2022, the EMA GMP/GDP Inspector Working Group and PIC/S published the Concept Paper on the revision of Annex 11: Computerised Systems for comment. Read about the comments prepared by an ECA Foundation / European QP Association Expert Group.
6 February 2023
ECA Groups issue report on their Activities from September through December 2022
Please see the ECA Foundation Interest Groups' report to find out what they were working on and accomplished in the four months from September through December 2022.
3 January 2023
Expert Working Group submits Comments to FDA draft Guidance on CSA
The draft of Guidance on CSA, Computer Software Assurance, was published in September last year. Find out more about the background and the comprehensive comments provided by the ECA Expert Working Group.
15 December 2022
New Version of GMP, GCP and GDP Data Governance and Data Integrity Guide available
The ECA Foundation just published version 3.0 of the GMP, GCP and GDP Data Governance and Data Integrity Guide. This very comprehensive document was prepared by the experts of the ECA Analytical Quality Control Group and the Data Integrity & IT Compliance Group in close collaboration.
8 December 2022
Expert Task Force issues new Version of CCS Guideline
With the publication of the final version of the revised Annex 1 in August, the ECA Foundation's CCS Task Force got together again to update the CCS Guide based on the final Annex 1 version. The new CCS Guide version 2.0 now comprises the revision of quoted passages, the modification and insertion of individual sections and tables as well as an improved clarity and the update of the attachments.
5 October 2022
ECA Groups inform about their Activities from May through August 2022
The ECA’s Interest and Working Groups inform regularly about their current activities and accomplishments. In the following you’ll find their report for the months from May to August 2022.
24 August 2022
ECA's Analytical Quality Control Group provides feedback to EMA public consultation on ICH Q2 and Q14
The ECA Foundation together with its European QP Association provided feedback to the EMA's public consultation on the ICH Q2(R2) and Q14 guidelines, which was prepared by the Foundation's Analytical Quality Control Group on their behalf.
20 July 2022
Expert Task Force updates CCS Guideline
Almost 1,600 interested colleagues downloaded version 1 of the ECA Expert Task Force's Contamination Control Strategy Guide from the ECA Foundation website - and numerous comments came in. This feedback has now been incorporated into a revised version of the CCS Guide.
5 July 2022
ECA Group Update January to April 2022
What were the ECA Foundation's Interest and Working Groups working on in the first four months of 2022? Please see their report to find out more.
4 April 2022
ECA Expert Working Group submits Comments to ICH Q9 Draft
The draft of a planned revision of the ICH Q9 Guideline was published in December. Find out more about the reasons for the revision of ICH Q9 and the comprehensive comments provided by the ECA Expert Working Group.
28 February 2022
ECA Foundation and European QP Association inform about the Passing of their former Chairman
With deep sadness the ECA Foundation and its European QP Association advise that our friend and colleague, Richard (Dick) Bonner passed away in February 2022.
8 February 2022
NEW ECA Contamination Control Strategy Task Force CCS Guide
To support its members, but also to support industry in general, in implementing the requirement of the upcoming revised Annex 1 for a Contamination Control Strategy, the ECA's new Task Force has developed and published a Guideline on Contamination Control Strategy.
7 February 2022
ECA Group Update September through December 2021
The ECA’s Interest and Working Groups inform regularly about their current activities and accomplishments. In the following you’ll find their report for the last four months of 2021.
12. November 2021
ECA Group Update May to August 2021
What were the ECA Interest and Working Groups working on from May to August 2021? Find out in their report.
16. August 2021
ECA Foundation extends Executive Advisory Board
The ECA Foundation has extended its Executive Board. David Cockburn has accepted the invitation to join the ECA’s Executive Board with immediate effect. Find out more about the Board Extension.
15. June 2021
ECA Group Update January to April 2021
Find out what the ECA Interest and Working Groups were working on and what they accomplished in the first third of 2021.
26. January 2021
ECA Group Update Fourth Quarter 2020
As in every quarter, the ECA’s Interest and Working Groups also inform about their accomplishments and activities in the last quarter of 2020.
02. November 2020
ECA Group Update Third Quarter 2020
Find out about theECA Foundation Interest and Working Groups’ activities in the third quarter 2020.
04. February 2020
ECA Group Update Fourth Quarter 2019
What were the ECA Foundation Interest and Working Groups’ activities in the past three months? To find out please read their fourth quarter 2019 report.
9. November 2019
Summary of the ECA Foundation Interest Groups' Q3 activities
A new summary of the ECA Interest and Working Groups' activities is available in the Q3 report.
05. August 2019
ECA Foundation Interest Groups report about the Q2 activities
What the ECA Foundation's Interest Groups. worked on and accomplished from April through June 2019 is summarized in the ECA Foundation Interest Groups' Q2 report.
26. July 2019
ECA Foundation added to EMA List of Stakeholder Organisations
The ECA Foundation was recently accepted to the European Medicines Agency's List of Stakeholder Organisations. With the listing the EMA confirmed that the ECA fulfills the authority's eligibility criteria.
17. April 2019
ECA Interest Groups report on Q1 Accomplishments
Please read what the ECA Foundation's Interest Groups were working on and accomplished in the first quarter 2019 - in their Q1 2019 report.
22. January 2019
ECA Interest Groups report on Q4 Accomplishments
The ECA Foundation's Interest Groups regularly inform about their accomplishments. What they were working on in the last quarter 2018 and what they accomplished is summarized in their report.
22. October 2018
ECA Group Update Third Quarter 2018
Alike in the previous quarters, the ECA’s Interest and Working Groups also inform about their accomplishments and current activities in the third quarter 2018.
01. August 2018
ECA Group Update Second Quarter 2018
Every quarter the ECA’s Interest and Working Groups inform about their accomplishments and current activities. In the following you’ll find their report for the second quarter 2018.
09. May 2018
ECA Group Update First Quarter 2018
What were the ECA Foundation Interest and Working Groups’ activities in the past three months? To find out please read their first quarter 2018 report.
29. March 2018
ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide
With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.
27. March 2018
ECA Foundation submits comprehensive comments on Annex 1 Revision to EU Commission
On 20 December, the European Commission had published the long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU Guideline for Good Manufacturing Practice for Drug Products and Drug Substances – and asked in a targeted stakeholders consultation for comments until 20th March 2018. Find out more about the comprehensive comments the ECA Foundation submitted to the EU Commission’s EU Annex 1 draft.
27. February 2018
ECA Foundation establishes new ATMP Interest Group
Advanced Therapy Medicinal Products (ATMP) are a new emerging class of innovative biopharmaceutical medicines, summarizing gene therapy, somatic cell therapy and tissue-engineered products. Now the ECA Foundation has established the new ATMP Interest Group to support their members with information and guidance.
05. February 2018
ECA Group Update Fourth Quarter 2017
Please read what the ECA Interest and Working Groups accomplished in the last quarter 2017 – in their report for the fourth quarter 2017.
If you are interested in reading news from 2017 and before, please contact us.