UK Scottish Region Affiliate

ISPE UK Scottish Region Affiliate arranged a site visit to Intercell Miomedical Ltd. on 3 November 2009 in Livingston, Scotland. This event gave insight into some of the challenges of successfully moving a small development site into a commercial manufacturer. The event included an introduction to Intercell and its technologies followed by a review of the journey made at the Livingston site in the transition from development to commercial manufacture of a Japanese Encephalitis virus vaccine. This was followed by a tour of the manufacturing facilities.

Speakers for this event included David Venables, Site Director, Intercell Biomedical Ltd, Scotland.

Nordic Affiliate

ISPE Nordic Affiliate hosted, “Use of IT-tools in a GxP environment,” on 20 November 2009 in Copenhagen. This half-day GAMP Forum meeting focused on IT-tools in a GxP environment. The meeting attained a high degree of delegate participation and the presentations were kept short allowing time for questions and discussions.

Topics that were covered during this event included:

• Trends and regulatory news - round table discussion
• How automated test tools are managed efficiently - procedures and controls
• How automated test tools can be used or validation - principles and examples
• How compliance and control of infrastructure tools are implemented - part 1: procedures and controls
• How compliance and control of infrastructure tools are implemented - part 2: examples

Speakers for this event included Jesper Hammerstrøm; Michael Herløv Jensen, NNE Pharmaplan; and Hasse Greiner, Novo Nordisk A/S.

ISPE Nordic Affiliate upcoming events include the following:

GAMP Meeting
Date: 11 March 2010
Location: Oslo, Norway
Programme TBD

Water and Steam Including New Baseline Guide
Date: 13 April 2010
Location: Finland
Programme TBD

Italy Affiliate

On 10 December, ISPE Italy Affiliate organised in Milan its end-of-the-year meeting for Members as well as non-members interested in the ISPE activities in Milan, Italy. The evening programme included an overview on the ongoing ISPE activities as well as a recap on the activities of the Italy GAMP Forum, including the best from the workshop “Improving efficiency of Verification phases in GAMP 5 perspective” held in Parma on 14 May 2009. Operational Excellence in Italy was discussed as well, relative to the workshop “Pharma Operational Excellence” held in Milan on 15 October 2009. University Relations was also a topic of discussion, as well as the upcoming 2010 Milan Congress and ISPE/PDA Conference at Pharmintech. The meeting was concluded with a traditional Christmas dinner.

Czech Republic and Slovakia Affiliate

The 7th Annual Conference of the Czech and Slovak ISPE Affiliate was hosted by Hungary on 27-28 November 2009 at the Hotel Gellert, Budapest, Hungary and Teva Hungary, Gödölö. (Hungary has not established their own Affiliate yet, but it participates in the existence and work of the global society.) This notable event included not only a theoretical part consisting of presentations, but a practical part as well: an opportunity for the attendees to visit the TEVA Hungary facility.

Speakers for this event included Lajos Hegedus,Teva Hungary; Jiri Moninec, Affiliate Chairman; Alexandra Kolasinova, Affiliate Committee Member; and Laszló Buzás, Hungarian Pharmaceutical Manufacturers Association.

Germany/Austria/Switzerland (DACH) Affiliate

ISPE DACH Affiliate hosted its third workshop, “GMP and Operator Protection – New Technologies in Powder Filling” on 23 October 2009 at Fellbach and Waiblingen in Germany.

Around 30 participants from pharma industry, engineering companies and suppliers from Germany, Austria and Switzerland updated their knowledge on the latest status of Guidelines/Technical Concepts and Solutions, as well as learned practical manufacturing experiences with those through presentations, discussions and case studies of pharmaceutical users. The event also included a company visit at Bosch Pharma Solids.

Major focus was given to the question of how GMP requirements and operator protection concepts are combined in safe, efficient and economical production solutions for oral solid dosage forms. An update on the latest activities of ISPE regarding the revision of the Baseline® Guide for Oral Solid Dosage Forms added a more general view and gave a perspective on what can be expected from the next revision. Insightful case study presentations including movies of major solutions gave a clear view on today’s concepts. The Q&A session demonstrated a strong interest in this topical subject and the feedback received after the event was very encouraging.

Speakers for this event included Moderator Dr. Frank D. Scholl, Committee Member D/A/CH Affiliate; Dr. Thorsten Schmidt-Bader, MoveproTec, Germany; Dr. Bernd Mümmler, Excella GmbH, Germany; Thomas Cragnolini, Siegfried Ltd, Switzerland; and Dr. Clemens Stief, Pfizer GmbH, Germany.

One participant said, “It has been really worthwhile coming to this event. Good that I participated.”

One of the speakers said, “I am happy that I was able to contribute to this successful event.”

Company visit at Bosch Pharma Solids

Attendees at the DACH Affiliate workshop

New Members

In September and October, ISPE welcomed 231 new Members in Europe. Find out who joined!