Press Announcements 2017

EDQM published Press Release on microbiological Control Symposium

Two weeks after their microbiology symposium in Strasbourg, the European Directory for the Quality of Medicines and HealthCare (EDQM) summarized the event in their press release entitled "Microbiological control symposium: consensus on readiness of new methods emerges"

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Welcome Message by the Governing Mayor of Berlin

APIC/CEFIC will celebrate it´s 20th European API Conference in Berlin. You will meet more than 200 participants from more than 25 countries at the leading conference of its kind. Seven speakers from authorities and 13 speakers from pharmaceutical/API manufacturers will discuss the latest trends like ICH Q12, the EU/FDA MRA Agreement, Data Integrity, Continuous API Manfucturing and many more topics. Please read the agenda of the European API Conference.

How to document a Product Transfer? Get Example Templates!

As a participant of the GMP training course "Product Transfer" you will receive a USB-Stick with example documents, templates and guidelines for site change projects.

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ECA Guide on Visual Inspection: Current Version for all Participants of the Particles Event

Participants of the ECA Conference Particles in Parenterals will receive the current version of ECA's Guidance Document on Visual Inspection of Parenterals free of charge.

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European GDP Association anounces new Advisory Board Member

The European GDP Association, representing close to 1.900 professionals from across the globe, has announced that it extended its Advisory Board. So far the Board comprised four members from the industry side, supported by a representative from the Finnish Medicines Agency FIMEA. Read more about the new Advisory Board Member of the GDP Association.

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ECA publishes Position Paper regarding Container-/Closure-Integrity Testing

There seems to be an increasing uncertainty in the pharmaceutical industry regarding the integrity testing of sterile containers. That's why the Board of the ECA Visual Inspection Group worked on a position paper regarding container-/closure integrity testing of sterile injectables.

 

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The new Elemental Impurities Database for Excipients - a valuable support for performing risk assessments according to ICH Q3D

Excipients come from a wide variety of sources, and suppliers do not always provide sufficient information. Therefore, some pharmaceutical companies in a consortium have launched an initiative to facilitate the risk assessment of excipients.

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Become part of the Pharma Congress 2018 - as a Speaker

Become part of the Pharma Congress 2018 as a speaker and benefit from the information exchange with other industry experts in the speakers’ team! As before the motto of next year's Pharma Congress from 24-25 April is “Users report for Users”. And for that reason we are looking for practical contributions from pharmaceutical companies - and look forward to receiving your proposal for a presentation which you can still submit until 14th June.

European GDP Association nominates new Advisory Board Member

So far the Board of the European GDP Association comprised four members from the industry side and is supported by a representative from the Finnish Medicines Agency FIMEA. Now the GDP Association announced the extension of its Advisory Board.

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How to deal with Insoluble Matter and Foreign Particles in APIs

A topic of great interest to the pharmaceutical industry and quite often a matter of concern during authority inspections is foreign particles in Active Pharmaceutical Ingredients (APIs) and related intermediates.

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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.

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, its implementation will generate 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 from more than 20 countries can be found on the European GMP Conference website. 

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 ECA Members. In the Members Area you will find the GMP Guideline Manager and also all FDA Warning Letters related to GMP issues broken down according to Fiscal Years and type of production (Biologics, APIs etc). The GMP Discussion Forum moved to the ECA Members Area as well. This will allow you as ECA Member to discuss 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. Take a look for yourself - just login into the ECA Members Area.

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