Press Announcements 2010

US Conference on European Pharma Regulation and the Role of the QP

International collaborations, mergers and acquisitions and more complex supply chains require the globalized pharmaceutical industry to acquire a better understanding of pharmaceutical legislation throughout the world. To support the pharmaceutical industry outside Europe in understanding the European approach and legal framework, the European QP Association together with the European Compliance Academy (ECA) will conduct the conference "Understand European GMPs and the Role of the QP" in the USA.

Implementation of the new Annex 1 Requirements for Crimping/Capping

The revision of the EU GMP Guide Annex 1 "Manufacture of Sterile Medicinal Products" introduced new requirements for the crimping/capping of vials in 2008. These new requirements were partly debated quite controversially. Nevertheless, they had to be implemented until 1 March 2010. A partly ambiguous definition still left some room for interpretation. To find out the current industry state of the art with regard to the crimping/capping of vials we generated a survey.

Survey: WFI Production through Reverse Osmosis

Two weeks ago we invited you to participate in our survey on the manufacture of water for injection (WFI) through reverse osmosis. If you have't had a chance yet to complete the survey - here it is for suppliers of pharmaceutical water systems and for users of water systems in pharmaceutical companies. The survey is still open until 29 November.

Speakers from FDA and Group 1 of the European Pharmacopoeia at the RMM Conference 2010

In 2010 Bryan Riley from the US Authority FDA as well as Sylvie Guyomard from ACM Pharma, France and Geert Verdonk, MSD, both members of the Group 1 of European Pharmacopoeia will present at the Rapid Microbiological Methods Conference in Budapest, Hungary, from 8-9 December 2010. For more Information please visit www.microbiology-conference.org.

Survey: WFI Production through Reverse Osmosis

According to the Ph.Eur., WFI (water for injection) has to be produced through distillation. In the US, though, it is also possible to do this through the membrane method. The discussion, to also approve cold manufactured WFI in Europe, has been going on for a while already. The EDQM asked associations to participate in a survey to find out more about the current state of technology and about possibly needed modifications of the Ph.EU. But is the approval of the reverse osmosis for producing WFI actually interesting for you? Participate in our survey for suppliers of pharmaceutical water systems or users of water systems in pharmaceutical companies.

Who are the Persons involved in ECA Foundation?

In the past years, the ECA Foundation has attracted a lot of attention from both authorities and industry. Today, it is Europe´s leading organisation in the field of pharmaceutical Quality Assurance and GMP Compliance. Many colleagues from industry and authorities support the ECA Foundation and their interest groups. A new organisation chart explains their role. Go here to see the chart.

Event on European Pharma Regulation and Role of the QP in the US

The ECA and the European QP Association are currently evaluating the possibility of running training courses on European GMP requirements and the role of the QP outside Europe, amongst others in the U.S.A. Please read more here.

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ECA Foundation offers Student Programme

To allow students to attend ECA Conferences and Education Courses, the ECA Foundation now offers a Student Programme with special fees. Read more here.

Do you already use the GMP News RSS Feed and Google Gadget?

To receive information on current GMP trends even faster, you will find two very usefull functions on the ECA website. After subscribing to the RSS Feed, it will automatically show you new entries as soon as they appear on the ECA GMP Compliance website. By using the GMP gadget, Google automatically updates the content every time the user opens iGoogle. This means that, in the future, you will automatically get a preview of the latest GMP news. You will find more information here

Video Address of ECA Foundation Chairman

With the beginning of 2010 the European Compliance Academy (ECA) was transferred to the ECA Foundation - comprising a non-profit educational organisation, the ECA Academy, and two non-profit interest groups. To get an update on the latest developments with regard to the ECA and to watch the video address of Daniel Scheidegger, ECA Foundation Chairman, please go here.

ECA publishes Version 5 of the "GMP/ISO Matrix"

Version 5 of the ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -" is know available. You will find more here.

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European Compliance Academy (ECA) nominates Dr Jean-Denis Mallet as new Advisory Board Member

The European Compliance Academy (ECA) announced today that it nominated Dr Jean-Denis Mallet as new Advisory Board Member. Read on here.

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New Version 12.0 of the GMP Guideline Manager released with new features

The GMP Guideline Manager Software contains over 1,100 GMP guidelines, including FDA, EC, PIC/S and ICH as well as Good Practice Guides from major organisation such as APIC/CEFIC and IPEC. The new version 12.0 was released recently. Click here for more information.

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New edition of the EU GMP Guide Paperback

A new edition of the EU GMP Guide is available as paperback version. It does not only contain the current Parts 1 (Medicinal Products) and 2 (APIs) but also the new draft Part 3 (Site Master File). The new version also comprises the latest changes in Annex 3 and 7. You can purchase the EU GMP Guide as well as other GMP Guidelines - e.g. the FDA cGMP Guide - on the ECA Webpage. ECA Members receive a discount. Here you will find more.

Geneva: Bio Production Forum including Site Visit at Merck Serono

From 15-17 June 2010, the 6th Bio Production Forum takes place in Geneva, Switzerland. Development and manufacturing of Biopharmaceuticals is a process chain with high value as well as high ethical values. For both reasons it is of utmost importance to manufacture drug products satisfying highest available quality standards. Therefore, ECA has dedicated this conference solely to these important steps in biopharmaceutical manufacture. You will find more at www.bio-conference.org.

The successful ECA GMP Certification Programme is extended – now the organisation offers 11 advanced training programmes.

APIC Audit at Boehringer Ingelheim

With the APIC Audit Programme, the organisation, a sector group of the European Chemical Industry Association, has defined a commonly acknowledged standard for so-called shared audits. Renowned API manufacturers like Genzyme in Liestal, Switzerland, and Pfizer Kalamazoo (USA) have already passed the programme - alike Boehringer Ingelheim with its largest API manufacturing site. Find out more.

GMP Conferences by Topics

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