Affiliate News

Belgium Affiliate

Chairman - Jef De Clercq

In an attempt to further intensify Belgium Affiliate Board meetings, a number of initiatives have been deployed since the beginning of 2002. The first initiative is creating a calendar of meeting dates for the entire year. As a general rule, Board meetings will take place the second Thursday of each month. This allows participants to better book their agendas, anticipate possible absences, provide a replacement if needed, and better prepare for meetings. Puurs and Brussels have been identified as meeting places. Both locations are easily accessible for the attendees of Flanders, Brussels and the Walloon region. In the past, several pharmaceutical companies were represented by only one delegate of the Affiliate Board. It has now become general practice to formally list two delegates per company, who can act as a replacement for each other in case of absence. For representation on the Board, the focus has been on pharmaceutical companies with a substantial manufacturing presence in Belgium. In addition to Schering-Plough, Janssen, Pharmaceutica, Pharmacia, GlaxoSmithKline, Steritec, U.C.B., Innogenetics, and Alcon Labs, two representatives from Pfizer and Baxter recently agreed to join the Board meetings. Other companies also have expressed their interest to participate.

An overall increase in interest for Board meetings has been noted. Since the beginning of 2001, more and more companies have contacted the Belgium Affiliate Board regarding participation in Discussion Forums within the Affiliate. Pharmaceutical companies located in Belgium that are not yet represented on the Affiliate Board or Discussion Forums and are interested in joining, contact Jef De Clercq, Belgium Affiliate Chairman, for more information.

Activities 2007

Topics discussed:

- From glass and stainless steel to plastic
- Membrane chromatography applications in biopharma production
- Manufacturing strategy for single use technology
- The utilization of disposable equipment for increased mfg flexibility
- Validation of single use systems
- Implementation & Validation of single use mfg from the design phase
- Contained transfer of powder and solids using disposable systems
- Validation of a disposable mfg line including weighing, mixing and filling with single use isolator.

Activities 2006

Technical Seminar April 26th 2006

Environmental Monitoring and Media Fill

strong>Technical Seminar December 19th 2006

HVAC and Containment systems in Pharma Facilities

Activities 2005

	Technical Meeting June 21th 2005
	Continuous Improvement - Sustainability

	Seminar: November 28th 2005
	Packaging, Labeling & Warehouse Operations plus Plant Visit Pfizer Warehouse

Activities 2004

	Yearly SIG meeting - Radisson SAS, Brussels, May 13th, 2004.
	For details consult section : "Special Interest groups"

	Technical meeting 25/11/2004
	Desinfection and Decontamination in the Pharma Industry

Activities 2003

	March 2003 - SIG
	ISPE Belgium - Operational SIG's 2002

	Technical Meeting 25/11/2003
	Aseptic Guidelines
	General Overview of irradiation technology

Activities 2002

January 25th 2002 - SIG HVAC

Companies present: Janssen Pharmaceutica, Pharmacia & Upjohn, Schering Plough, Solvay, Alcon
The subject of the meeting was on overpressure control of cleanrooms.

Shared Interest Group Production:
28/03/02 - Focussing on use of Isolators in Sterile Manufacturing - Pharmacia

March 28th 2002 - SIG Qualification/Validation

Location: Janssen Pharmaceutica, Beerse

Participants: Ann Faseur (Solvay), Laurence Champenois (Eli Lilly), Benjamin Michot (Eli Lilly), Paul Meeussen (Alcon), Eddy Goossens (Schering Plough), Geert Callaerts (Innogenetics), Mike Colle (Innogenetics), Eric Lambert (GlaxoSmithKline), Jo Leen (Janssen Pharmaceutica), Etienne Compernolle (Janssen Pharmaceutica), Patrick Ingels (Janssen Pharmaceutica), Ivan Baeten (Janssen Pharmaceutica)

Excused: V. Spits (UCB)

The discussion on the Design Qualification was reopend. Other topics were discussed:

ISPE Baseline: Commissioning and Qualification
Determination of GXP criticality
Preservation of the validated status of a system. Validation master planning versus Project validation plan
Presentation: Performance of shake-down tests and the execution of qualification after shake-down tests

One-day seminar on May 15, 2002 at Hotel Serwir, St-Niklaas

Topic: Isolator Technology: State of the Art
Participants: 125
Annex: Plant visit: Pharmacia

Evaluation:
Extremely successful
Very good speakers + case studies (4)
Plant visit well organised and interesting
Limited very specific table top exhibition

New members: 40

October 7th 2002 - SIG Qualification/Validation

Discussion of following topics:

Testing
Preservation of the validation status
Content of the IQ protocol of a Product Water System
Costs & measurements
Failure Mode Analysis

October 2002 - SIG HVAC 'life cycle costs' (Presentation given by R. De Hertogh from ABB)

Shared Interest Group Production:
28/11/02 Focussing on use of automated or manual Visual Control - Alcon

Next to sharing experiences, networking of responsibles within the production domain is clearly one of the assets. During 2003, other topics will be tackeld. Each shared interest group meeting is concluded by a plant visit. Representatives of 7 companies are attending: Alcon, GlaxoSmithKline, Innogenetics, Janssen Pharmaceutica, Pharmacia, Schering-Plough and UCB.

Shared Interest Group Quality in Research and Development: The kick-off meeting is scheduled for 09.12.02. During this first meeting one of the companies will present their Product Design procedure, focussing on how they integrate Quality within the proces. In 2003 critical challenges will be discussed. Representatives of 4 companies are attending: GlaxoSmithKline, Innogenetics, Janssen Pharmaceutica and UCB.

November 20 - Technical meeting

Topic: GAMP IV and Part 11 Compliance for Management
Duration: 09.00-12.30h + lunch
Program:

	08.30-09.00h Registration
	09.00-09.10h ISPE Belgium - Welcome (JDC)
	09.10-09.40h General introduction (Marc Senterre - UCB)
	09.40-10.10h Gamp IV (Alain Fortpied - GSK)
	10.10-10.30h Coffee break
	10.30-11.00h Simularities between US (Part 11) & European (Annex 11) guidelines (Patrick Hacour - SPL)
	11.00-11.30h Personal interpretation on 21CFR, Part 11 (Per Olson - ABB Eutech)
	11.30-12.00h Case study (Walter Lauwers - JPh)
	12.00-12.15h Q&A session
	12.15-12.30h Reception
	12.30-13.30h Lunch

Place: Salons de Romrée
Price

	Members and Academic people: 75 Euro
	Non-members: 245 Euro

Activities 2001

	Seminar on November 21, 2001 at Janssen Pharmaceutica
	Topic: latest trends in pharmaceutical packaging Participants: 85 Annex: plant visit: Janssen Pharmaceutica Evaluation: Big success Speakers very good Case studies highly appreciated Plant visit (Janssen) excellent New members: ca 25

	Start up of SIG's (discussion forums)
	3 major groups: engineering production QA/QC Engineering group subdivided into 12 SIG's participants from 6 major manufacturers Bi-monthly meeting per SIG Topics (see list)

	June 15th 2001 - SIG Clean Process and Piping
	Location: Solvay Research & Technology Center, Brussels Participants: Chris Van Offenwert (Janssen Pharmaceutica), Eric Peeters (Janssen Pharmaceutica), Paul Van Vliet (Alcon Couvreur), Wenke Devriese (Alcon Couvreur), Corneel Festraets (Pharmacia), Xavier Bouquet (Pharmacia), Sylvie Wiellaume (GSK), Paul Corin (GSK), Bert Van Den Bosch (Solvay Pharmaceuticals Olst (NL)), Alexander Mulder (Solvay Pharmaceuticals Olst (NL)), Paul Van Moer (Peptisyntha), Sail Philippe (Solvay) Excused: Y. Vanderwegen (Alcon Couvreur), L. Vermeiren (Janssen Pharmaceutica), J-M. Decock (UCB) Subject: Clean Process and Piping The aspects of maintenance, qualification & validation, FDA compliance are discussed for the following topics: Water and steam systems Sanitary piping and fittings cleaning technology clean equipment

	September 28th 2001 - SIG Water & Steam Systems
	Location: Pharmacia Puurs Discussion on following topics: Results of survey on water production & distribution systems Comments on ISPE baseline guide on 'Water & Steam Systems' in-line with survey Rouging Connection from distribution loops to equipment Experience with RO/CDI Biofilm, passivation and sanitizing Water specifications Site visit Pharmacia

	Yearly annual SIG meeting
	December 6, 2001 VIP restaurant GlaxoSmithKline Rixensart Attendees: sponsors of SIG-groups + ISPE Committee members Planning for coming year

* Total n° ISPE members: 360