A Column for Discussion of Issues Identified by Readers of the Journal of GXP Compliance and the Current Good Practice for Resolution of the Issues. This column is one of a continuing series in which...
Microbiology and microbiological processes have are some of the mostly widely regulated and scrutinized activities in pharmaceutical and medical device manufacturing. Recently, rapid microbiological...
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The Winter and Spring Issues of the Journal of GXP Compliance featured papers on technical/quality agreements, devoloping test cases, academic GLP and GCLP programs, change control, and validating the SaaS application. The following questions are adapted from papers published in the Journal of GXP Compliance and are designed to test your knowledge of the best practices for global compliance.
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