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.
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.
method transfer activity validation
Good Control Laboratory Practices, 2 February,
Can anyone provide guideline on analytical method transfer from one site to other site wh ...
skip impurity testing in finished dosage forms
Good Control Laboratory Practices, 17 September,
During some documentation review I found out that a company skipped testing for impurities during re ...
Common microbiology incubator room?
Good Control Laboratory Practices, 6 March,
Can anyone advise whether it is advisable to have incubators for classical microbiology (where you w ...
Weighing Uncertainty / Minimum Weight
Good Control Laboratory Practices, 4 December,
Having completed the USP Section 41 "uncertainty" / minimum weight determination on all of our analy ...
Frequency of verification/ revalidation of analytical methods
Good Control Laboratory Practices, 30 October,
If a method has been validated or is a valid pharmapoeial method verified in a lab, what should be t ...