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About the GAMP COP

ISPE’s GAMP Community of Practice is comprised of like-minded professionals from around the world collaborating and interacting to address issues of common concern. The GAMP COP is governed by a Steering Committee of committed Volunteers who are subject matter experts in diverse fields.


 

COP Mission

The GAMP® COP exists to promote the understanding of the regulation and use of computer systems, control systems, and intelligent instruments (also called "computer systems") within the pharmaceutical, biopharmaceutical, or medical device company.


 

How to Get Involved

As a GAMP COP member you can access technical discussions or download presentations or files. You can complete a volunteer profile and share your expertise with the community. Note that only ISPE Members can engage in these activities.

Community Discussions

  • CALL FOR PAPER! Flexible Facilities European Conference
    GAMP, 10 May, (2 comments)
    Dear ISPE GAMP COP members, ISPE and the Flexible Facilities Programme Planning Committee are in ... Continue reading
  • how far we must go with spreadsheet validation
    GAMP, 2 May, (3 comments)
    Dear all, I have some questions related with, how far we must go to demostrate that our spreadshee ... Continue reading
  • Excel Spreadsheet as data container
    GAMP, 30 April, (5 comments)
    Situation is as follows: Excel sheets are used to store data about produced goods (batch number, MBP ... Continue reading
  • Validation of testing tools
    GAMP, 16 April, (3 comments)
    EU GMP Annex 11 section 4.7 states "Evidence of appropriate test methods and test scenarios should b ... Continue reading
  • Laboratory Equipment Part 11 SOP
    GAMP, 3 April, (5 comments)
    A company I am working with is looking for guidance/examples of SOPs providing direction for managin ... Continue reading