Press Announcements 2016

The ECA Foundation announced recently the formation of the European GDP Association on the basis of the already existing GDP Group.

The European GDP Association represents all stakeholders involved in Good Distribution Practice, e.g. from Pharmaceutical Industry and Authorities up to Logistic Providers. The Association is a not for profit organisation under the umbrella of the ECA Foundation. With this change, the GDP Association will be able to better communicate with authorities and will be actively involved in providing feedback on new GDP regulations and their interpretation. The Members Area provides documents like the GDP Interpretation Guide which has been developed in cooperation with the Pharmaceutical Quality Group (PQG) in the UK. Also, the Code of Practice for Responsible Persons and the supplier database are accessible there.

Current members of the GDP Group can transfer their membership to the GDP Association. Please find more about the GDP Association.

The ECA "Analytical Quality Control" Working Group's second project is the development of a Laboratory Data Management Guidance Document for the concrete handling of Out of Expectation (OOE) and Out of Trend (OOT) Results. Find out what Version 01 of this OOE/OOT Guidance Dokument covers on more than 70 pages.

Some months ago, version 2 of  ECA´s Good Practice Guide on Validation was published. On 174 pages the revised Good Practice Guide comprises the main elements of the new validation approach ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do"). The document is available at no costs if you register for the ECA Validation Group. To find out more we invite you to visit the ECA Validation Group's new website.

The validation of analytical procedures is a critical part of any process for ensuring drug quality. Since 2014, USP’s Validation and Verification Expert Panel has been considering how the modern concept of lifecycle model process validation can be applied to analytical procedures. The United States Pharmacopeial Convention (USP) and the ECA Academy therefore announce their cooperation in organising a joint conference entitled, “Lifecycle Approach to Analytical Procedures” in Prague.  Read more about the Press Release published by USP and ECA.

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.