Press Announcements 2017

Consequences of the new FDA/EU MRA agreement on GMP Inspection

The new MRA agreement between the EU and the US will already come into force on 1st November of this year. However, the implementation will cause a number of questions in practice. Maria-Jesus Alcaraz from EMA will present first-hand information at the 7th European GMP Conference on 31. May - 01. June 2017 in Prague. This event is organised only every two years by the ECA Academy, the European QP Association and several additional Interest Groups. More details about this unique event with delegates more than 20 countries can be found at www.gmp-conference.org

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.

Ensuring the Integrity of Production Data

Data integrity is one of the hottest topics currently discussed. This is also why public authorities have been paying more attention to the issue recently - as an impressive number of Warning Letters and Non-Compliance Reports have clearly shown in the last months. But what are the actual requirements of FDA, EU, WHO and PIC/S? What is demanded by management and personnel in production in terms of data governance? You can learn more about this at the Manufacturing Data Integrity conference as part of this year's Pharma Congress on 28/29 March in Düsseldorf. There you will also find out how the data life cycle in production is linked to business processes. Please see the Pharma Congress website for further information.

New ECA Academy Webpage - New Features and Services for Members

You may have already visited our new ECA Academy Webpage. For your convenience we tried to structure the webpage very similar to the previous version. But there are some changes for the benefit of the ECA Members. You will find the GMP Guideline Manager there and also all FDA Warning Letter related to GMP issues in a structured form. The GMP Discussion Forum moved to the ECA Members Area as well. This will allow the ECA Members to discuss their GMP questions in a closed community. Further information has been added like "Top Lectures" where you can access presentations which received a very high interest (e.g. presentations form EU and FDA Inspectors). And all articles from the GMP Journal can be accessed there as well. We recommend to login into the ECA Members Area

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. In the Members Area access will be provided to 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 still accessible.

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.

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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.

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.

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GMP Conferences by Topics

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