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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
The CAPA SOP describes the processes required actions
CAPA and responsibilities for identifying, processing and
SOP
resolving CAPA issues
The CAPA report describes the actual CAPA event and
CAPA provides a GMP record of how it was resolved. The
REPORT CAPA records will also be of interest to government
auditors.
The register provides a list of CAPA events and their
current status. From the register, managers can tell
CAPA which CAPA events are the most common, and what
REGISTER
stage they are at in being resolved. The register will also
be of interest to government auditors.
In addition to this documentation, best-practice CAPA systems also have the
following features:
in-built risk assessment
a means to trend CAPA to identify related issues
assigned responsibilities for CAPA actions
a system for identifying when a CAPA closeout has not been met
integration with management review meetings
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