ECA Foundation News
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.
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.
ECA Foundation issues Annual Report 2017
The ECA was founded in 1999. Since then the organisation has been receiving steadily growing interest. Today, eight Working and Interest Groups drive activities in specific areas. Form the start, these groups have been attracting continuous attention from both the industry and the authority side. Moreover, memberships in the Foundation's educational organisation, the ECA Academy, have also increased steadily throughout the past years. To get the complete picture about the ECA Foundation's and its Working and Interest Groups' activities in the past year, please see the ECA Annual Report 2017.
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.
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.
ECA Group Update Third Quarter 2017
To find out more about the ECA’s Interest and Working Groups accomplishments and current activities in the third quarter 2017 please read the report for the third quarter 2017.
ECA Group Update Second Quarter 2017
As in every quarter, please see the ECA Interest and Working Groups' report for the second quarter 2017 on what they already accomplished and are currently working on.
ECA Group Update First Quarter 2017
Every quarter the ECA’s Interest and Working Groups inform about their accomplishments and current activities. Please see their report for the first quarter 2017.
ECA publishes Annual Report 2016
Since its foundation in 1999 the ECA has been receiving tremendous interest. Since then, seven Working and Interest Groups were founded with the goal to drive activities in specific areas. These groups have been attracting continuous attention from both the industry and the authority side. Further, memberships in its educational organisation, the ECA Academy, increased again (to 4.000 compared to 3.500 the year before). Please see the ECA Annual Report for the year 2016 to get the complete picture about the activities of the ECA Foundation and its Working and Interest Groups.
Updates from ECA Interest Groups
To accomplish its goals the ECA Foundation established a number of working and interest groups in the last years.
For information on what they have accomplished so far please read the summary.
ECA Foundation announces Independent Authority Board (IAB) Members
Since June 2015 the ECA Foundation, the leading European organisation in the pharmaceutical quality assurance and GMP compliance environment, has been managed by an Executive Board and an Extended Board. In addition, the ECA set up an Advisory Committee encompassing authority representatives. Now the Foundation announced the members of the Independent Authority Board (IAB) .
The new Elemental Impurities Database for Excipients - ECA offers a meeting at no costs
A step-wise integrated risk-based approach to determine a control strategy for drug products according to ICH Q3D has to consider data from all kinds of potential sources for elemental impurities and in particular from excipients. Read more about the newly created Elemental Impurities Database as a valuable support for performing risk assessments for drug products.
New Website ECA Validation Group: Version 02 of ECA´s Good Practice Guide on Validation online available
The ECA Validation Group was founded in autumn 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. Now the Validation Group launched a new Website.
ECA Foundation announces new Board Structure
So far the ECA Foundation Advisory Board comprised 10 professionals from industry and authorities. During their last Board Meeting, on 10 June 2015, the Board set the course for the future with a new board structure.
DA/EU-GMP-Matrix completely revised by ECA Task Force
Especially globally operating pharma companies frequently face the question what differences there are between the US cGMP regulations (21 CFR 211) and the EU GMP Guide for Medicinal Products - and what parallels there are? You will find the answer in the completely revised FDA/EU GMP Matrix.
The ECA Academy, the educational organisation of the ECA Foundation, offers a new GDP Certification Scheme
Good Distribution Practice has been closely linked to Good Manufacturing Pracitices. Medicinal Products need to be handled by qualified personnel. Chapter 2 of the EU GDP Guideline defines that personnel involved in GDP activities should “receive initial and continuing training relevant to their role, based on written procedures and in accordance with a written training programme.” Furthermore the GDP Guide states that “a record of all training should be kept, and the effectiveness of training should be periodically assessed and documented.” The certification Programme of the ECA Academy aims at providing the necessary knowledge for personnel involved in GDP activities. Read more about the new ECA certified GDP Compliance Manager.
ECA Foundation with New Webpage and New Interest Groups
The ECA Foundation was founded 15 years ago and has been developing to Europe´s leading organisation in the field of GMP and Regulatory Compliance. In order to provide a better picture of the comprehensive activities of the ECA Fondation a new webpage has been developed. Please read more here.
ECA's Working Group "Visual Inspections" nominates Chair
The ECA Foundation established its "Visual Inspections" Working Group in December 2013. Now the group announced the nomination of Dr Tobias Posset as Chair. Read more.
ECA publishes the GMP Question & Answer Guide
The requirements defined in the GMP Guidelines often leave room for interpretation. However, regulators worldwide (EMA, FDA, TGA etc) sometimes publish frequently asked questions on GMP. In a new ECA document these Q&As are summarized in a single source. The Q&As are structured in 4 main GMP Areas (General GMPs, GMP for APIs, GMP for Medicinal Products, GMP for IMPs). The document contains 150 pages of Q&As and is available at no cost on the ECA Webpage. A first set of ECA Q&As have also been included and additional GMP Q&As are planned for the future. Here you can access the GMP Questions and Answers Guide.
ECA Best practice paper on visual inspection to be published in September 2014
The ECA working group on visual inspection, which was founded this year, is going to publish its first document during the ECA event Particles in Parenterals and beyond. Read more about ECA's Best practice paper on visual inspection.
ECA's GDP Working Group offers GDP Supplier Database
The GDP Group has been asked by its members to set up a supplier database to help colleagues in the pharmaceutical industry finding suppliers for certain GDP services. If you are working with a supplier organization we kindly ask you to provide some information for our database. The database is a non-commercial service at no costs and is intended to support our members. Please access the GDP Group Members Area to fill in the questionnaire.
The ECA Academy offers GMP Training Courses and Conferences in 10 European Cities
The ECA Academy organises GMP Training Courses and Conferences in different European cities. On our new page, you can search for events by venues. You will find events in Berlin, Vienna, Barcelona, Lisbon, Heidelberg, Munich, Budapest, Copenhagen, Duesseldorf and Prague. Click here to find GMP Training Courses and Conferences by venue.
ECA Analytical Quality Control Working Group - Final OOS SOP
ECA's working group Analytical Quality Control has developed a new general SOP on the handling of OOS results. This SOP was presented at the OOS Forum in Prague, the official launch conference for this SOP, in June 2012. At the Forum alternative approaches were discussed by representatives of industry and authority. The final ECA SOP came into force in August 2012. Get more information about the final OOS OOP.
Richard M. Bonner appointed as new Chairman of the European QP Association - Ulrich Kissel from Roche new Board Member
Dr Bernd Renger has been the European QP Association's Advisory Board Chairman since its foundation in 2006. Now he decided to step down from this position. Succeeding as Chairman is Richard M. Bonner, who has also been member of the Advisory Board since 2006. Read more.
ECA publishes Good Practice Guide on Process Validation
An ECA Working Group has developed a Version 1 of a Good Practice Guide on Validation. This document is intended to provide support to both regulators and industry. Read more about ECA's Good Practice Guide on Process Validation.
ECA conducts Survey on Revision of Process Validation Guideline
With regard to the EMA's announcement that they would revise their Note for Guidance on Process Validation from 2001 the ECA conducted a survey to find out industry's thoughts on those plans. More than 500 provided input. Read more about the Survey on Revision of the Process Validation Guideline.
Changes in the European QP Association Board
So far, the European QP Association has been led by four industry representatives and two authority representatives. Now the Board has decided on some extensions on both sides. Read more.
ECA Foundation announces Changes on its Board
After the untimely death of its chairman Daniel Scheidegger in September 2011, the ECA Foundation has now announced some changes on its Advisory Board. Read on here.
Dr Sven Deutschmann appointed Chairman of ECA´s Rapid Microbiological Working Group
The European Compliance Academy (ECA) announced today that it appointed Dr Sven Deutschmann as Chairman of its Working Group for Rapid Microbiological Methods (RMM). He follows Dr Bob Johnson who served as the second Chairman of the Group. Read more.
28 July 2006
ECA Foundation initiates Working Group for Rapid Microbiological Methods
To change the unfavourable competitive situation for the European pharmaceutical industry the European Compliance Academy (ECA) initiated a Rapid Microbiological Methods (RMM) Working Group. The group brought together 11 representatives from the European Pharmaceutical Industry and the German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institute (PEI); the European authorities will also participate. Read more about the initiation of the Rapid Microbiological Methods (RMM) Working Group.