All manufactures face FDA inspection with some regularity, and we know it can be a stressful experience. When we recently sat down with a former FDA employee, we asked them to use their 9-plus years...
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...
Cleanroom contamination can arise from a number of sources. Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. The paper discusses staff gowning and...
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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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