Press Announcements 2016

ECA Foundation Guidelines and Documents for Download

The ECA Foundation and it´s Interest Groups have developed a number of Guidelines, SOPs and other documents to support colleagues in industry with the implementation of GMP requirements. The ECA has decided to offer all documents for ECA Members at no cost. The available documents contain among others:- SOP on OOS Results- Guidance on how to deal with Out of Expectation and Out of Trend Results- Good Practice Guide for Qualified Person- Validation Guide- GDP Guide- Visual Inspection GuidePlease read more about how to obtain these Guidelines at the ECA Foundation Webpage

GDP Group has turned into GDP Association

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.

New Version of the ECA best practice guide on visual inspection available

After the 3rd edition of the ECA Best Practice Guide on Visual Inspection was presented at the ECA Conference on Particles in Parenterals in Barcelona in September, the new version is now also available for download on the ECA Visual Inspection Interest Group website. It's free of charge, you just need to register beforehand.

ECA Analytical QC Working Group issues comprehensive OOE/OOT Guidance Document

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.


ECA Task Force will publish Draft Data Integrity Guideline at Conference in October

Data Integrity has become one of the most frequently observed GMP deviations at FDA and EU Inspections. For that reason the ECA Foundation decided to set up a Task Force on Data Integrity in December 2015 - with the goal to provide Guidance for the implementation in practice. Read more about the ECA Guidance on Data Integrity.


ECA Good Practice Guide on Validation

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.

New Version of EU GMP FDA cGMP and ISO Matrix Available!

An ECA Working Group has worked on a major revision of the Good Practice Guide which is also well known as FDA/EU-GMP/ISO Matrix. The Matrix compares the FDA cGMP Guide, the EU GMP Guide and ISO 9001. Just recently the ISO standard was completely revised. Please read more about Version 19 of the FDA/EU-GMP/ISO Matrix.


USP and ECA Academy Co-Host New Conference on Lifecycle Approach to Analytical Procedures

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.


ECA releases Version 18 of GMP Guideline Manager

How to access ten thousand pages of GMP Guidelines from FDA, EMA, ICH, PIC/S, ICH, WHO and many other organisations worldwide? You can print them or purchase hundreds of booklets. Or, alternatively, you can take advantage of a software tool developed by the ECA Academy, allowing you to access to the most comprehensive GMP Guideline Database.


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.


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