Global Summary of Active SIGs

1

• Global Summary of Active SIGs

2
GAMP Americas

• USA SIG Summaries

3
Manufacturing Execution Systems

• Principal Region(s) USA
• Chair Ed Kanczewski ed_kanczewski_at_hotmail.com,
  Karen Donaldson karen.donaldson_at_pfizer.com
• Focus
• Achieving Compliant MES, via Validation, GAMP
  Life Cycle, etc
• Project Management of Defined Scope MES
  Implementation
• Program Management of MES (Global) Initiative
• Goal Good Practice Guide
• Target for completion 2006
• Status Editing following public comments
• Recruiting new members No

4
IT Quality

• Principal Region(s) USA
• Chair Bob Herr robert.r.herr_at_pfizer.com
• Focus Organizational aspects of managing quality
  and compliance in IT
• Goal Discussion group maybe a paper
• Target for completion N/A
• Status Discussion group ongoing
• Recruiting new members Yes

5
Data Migration

• Principal Region USA
• Chair Jerry Anderson, janderson_at_watson.com
• Focus Quality assurance and compliance issues
  during data migration efforts
• Goal 1. Pharmaceutical Engineering article,
  pointing to...
• Good practice guide white paper on Web
• Possible GAMP5 appendix
• Target for completion November 2006
• Status Writing white paper
• Recruiting new members No

6
JETTJoint Equipment Transition Team

• Principal Region(s) USA
• Chair Jim John jettchair_at_kc.rr.com
• Focus 1. Unit Operations Equipment
• Equipment/Control URSs
• Risk Assessment for Packaged Equipment
• Test Planning for Packaged Equipment
• Goal Develop Additional Example Documents
• Target for completion Continuing Group
• Status See website www.jettconsortium.com
• Recruiting new members Yes

7
Risk Management

• Principle Regions Global
• Chair Steve Coates coatess_at_wyeth.com Chris
  Clark Chris.Clark_at_napp.co.uk
• Focus To assist the healthcare industries,
  (including Ethical and OTC Pharmaceuticals,
  Medical Devices, and Biotechnology), and the
  international regulatory authorities in promoting
  public safety by the application of appropriate
  Risk Management methodologies to implementation
  and operation of automated systems, while
  ensuring the realization of business
  efficiencies, robust processes, and quality
  products.
• GoalTraining Materials Tool Box
• Target Completion 4Q, 2007(est.)
• Status Authoring
• Recruiting new members? No

8
RD Systems

• Principal Region(s) USA
• Chair Barbara Mullendore bmullendore_at_watsonpharm.
  com Ken Gray ken.k.gray_at_gsk.com
• Focus
• Application of GAMP principles in the RD
  environment
• IT quality and compliance accountability across
  the entities involved in pre-commercial drug life
  cycle phases
• Goal Article, series of articles, or Good
  Practice Guide
• Target for completion TBD
• Status Re-populated SIG just now ramping up
  after hiatus
• Recruiting new members Not at this time

9
Laboratory Systems

• Principal Region(s) USA
• Chair Lorrie Schuessler (Lorrie.Schuessler-1_at_gsk.
  com) and Kathy Gniecko (kathleen_a.gniecko_at_roche.c
  om)
• Focus Application of GAMP principles in the
  laboratory environment
• Goal Discussion group, maybe brief articles
• Target for completion N/A
• Status Establishing discussion group
• Recruiting new members Yes

10
Test Automation (proposed)

• Principal Region(s) USA
• Chair Radha Ramesh rramesh_at_celgene.com
• Focus
• Assessment of when and which test automation tool
  will be applicable
• What concomitant needs need to be addressed,
  for test automation to work out
• Describe some case studies of test automation and
  cost benefit analysis
• How and how not to use automation common
  pitfalls to avoid
• Goal White Paper
• Target for completion Q4, 2006
• Status Preliminary
• Recruiting new members Yes

11
GAMP Americas

• Brazil SIG Summaries

12
Computer System Validation Strategic Planning

• Principal Region(s) Brazil
• Chair Marcelo Decanio de Oliveira
  decanio_at_ita.boehringer-ingelheim.com
• Focus Guideline for management audience covering
  strategic planning focused on compliance and
  business risks, process improvement, robustness
  of systems and its associated financial aspects
• Goal White Paper
• Target for completion TBD
• Status First meeting to occur during April06
• Recruiting new members Yes

13
Portuguese Translation

• Principal Region(s) Brazil
• Chair Flavio Kawakami flavio.kawakami_at_doctorbit.c
  om.br
• Focus Translation of GAMP GPGs documentation
  into Portuguese
• Goal Translation of Infrastructure GPG and
  Testing GPG
• Target for completion Sep06
• Status Business Plan to be approved by Brazil
  Affiliate Board of Directors and ISPE
  International
• Recruiting new members No

14
GAMP Americas

• Puerto Rico SIG Summaries

15
System Retirement

• Principal Region(s) Puerto Rico and USA
• Chair Eddie Cordoves, ecordoves_at_yahoo.com and
  Carlos Bruzos, bruzosc_at_stis.net
• Focus GxP System retirement process. Data
  Migration and Archiving will be out of the
  Scope. 
• Goal Define and establish a guideline to
  retirement GxP systems. Final document targeted
  as a GAMP5 appendix.
• Target for completion 1Q-2Q07
• Status Planning
• Recruiting new members Yes

16
Spanish Translation (placeholder this SIG is not
yet organized)

• Principal Region(s) Puerto Rico
• Chair
• Focus  
• Goal Target for completion
• Status Planning
• Recruiting new members

17
GAMP Japan

• SIG Summaries

18
Translation and integration of term for Japanese
version of GAMP Good Practice Guide

• Principal Region(s) Japan
• Chair Hiroaki Aikawa aikawa_at_kajima.com
• Focus
• 1"Validation of Laboratory Computerized
  System 2"IT Infrastructure Control and
  Compliance
• Goal Publication of the official Japanese
  version of GPG
• Target for completion Within 2006
• Status Early-stage
• Recruiting new members Yes

19
Study of operation to apply GAMP4 for real site

• Principal Region(s) Japan
• Chair Noboru Wakiyama
• Noboru.Wakiyama_at_jp.yokogawa.com
• Focus
• Study of concrete operation to apply GAMP4 for
  real site
• taking factors that is specific to Japanese
  market into
• account
• Goal Maybe a paper
• Target for completion about the middle of 2007
• Status Early-stage
• Recruiting new members Yes

20
Study of Change Control in case of System
Operation

• Principal Region(s) Japan
• Chair Rika Naito r-naito_at_nm.mbcl.co.jp
• Focus
• Study of Change Control in System Operation
• for the purpose of Maintaining the Validated
  State
• Goal Maybe a paper
• Target for completion about the middle of 2007
• Status Early-stage
• Recruiting new members Yes

21
Retrospective CSV

• Principal Region(s) Japan
• Chair Yuichi Fujita r-yufujita_at_ga.toyo-eng.co.jp
• Focus
• Study of retrospective computerized system
  validation
• Goal Maybe a paper
• Target for completion about the second quarter
  of 2007
• Status Early-stage
• Recruiting new members Yes

22
GAMP Europe

• SIG Summaries

23
Electronic Data Archiving

• Principal Region(s) EU
• Chair Per Olsson per.olsson_at_gb.abb.com
• Focus Raise awareness of the issues surrounding
  electronic data archiving and provide common
  understanding
• Goal Produce a template for a electronic data
  archiving strategy
• Target for completion Q4 2006
• Status GPG has completed external review and SIG
  are reviewing/incorporating comments. To be sent
  to ERB / Council for final review.
• Recruiting new members No

24
Maintaining The Validated State

• Principal Region(s) UK
• Chair Kate Samways kasassociates_at_btinternet.com
• Focus To define best practice and co-ordinate in
  line with other GPGs e.g. Data Archiving,
  Laboratory Systems, Infrastructure etc..
• Goal TBD
• Target for completion TBD
• Status Planning / Recruiting
• Recruiting new members Yes

25
Process Control Systems

• Principal Region(s) UK
• Chair Mark Cherry mark.cherry_at_astrazeneca.com
• Focus
• Review / revise GAMP Good Practice Guide
  Validation of Process Control Systems (VPCS)
• Accommodate recent significant developments in
  new technology (e.g. the use of PAT and RFID).
• Align with recent related GAMP GPGs (e.g. Risk
  Based Approach to Compliant ERES and Testing of
  GxP Systems)
• Enhance harmonisation with (next version of) the
  CQ Baseline Guides in line with a science and
  risk based approach
• Goal Publish VPCS GPG Version 2
• Target for completion Q3, 2007 (provisionally)
• Status Core team in place establishing
  document structure
• Recruiting new members Yes

26
Small Manufacturing Devices

• Principal Region(s) D-A-CH
• Chair Frank Benisch frank.behnisch_at_zlbbehring.com
  
• Focus Clarification of terminology (apparatus
  vs. device)
• Goal Possible Good Practice Guide
• Target for completion 2006
• Status
• Final draft completed Q3 2005
• Drafts directly written in English
• Document is effectively completed and is due to
  be sent to the Editorial Review Board by March
  2006
• Recruiting new members No

27
Supplier Cooperation

• Principal Region(s) D-A-CH / UK
• Chair Heinrich Hambloch hhambloch_at_hhambloch.de
• Focus Clarify Supplier / User responsibilities
  per GAMP life cycle software category via an
  improved user/supplier cooperation model
• Goal Possible article in PE or published via
  website as supplement to existing GAMP 4
  Appendices
• Target for completion 12/06
• Status Seminar scheduled in Brussels ISPE
  Conference, 12/06
• Recruiting new members No

28
Open Source Software

• Principal Region(s) D-A-CH
• Chair Thomas Makaitthomas.makait_at_sanofi-aventis.
  com
• Focus Use of Open Source Software (OSS) in the
  regulated health care industry
• Goal Create a common, technically sound approach
  for the use of OSS in the health care industries
  that is understood by users, suppliers and
  regulators. Clarify the division of
  responsibilities between OSS community, suppliers
  and users.
• Target for completion To be confirmed
• Status SIG founded in 03/2006, work packages
  have been distributed amongst the members
• Recruiting new members No