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.
FDA/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.
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