What is CAPA per ICH Q10?
(Corrective and Preventive Actions)
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the
level of risk, in line with ICH Q9.
What is CAPA?
How CAPA developed in Biotech
The Desired State
Enablers for an Effective CAPA System
Continue at: https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/ucm334579.pdf
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