Page 20 - QA and QC
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GMP Training – Quality Assurance and Quality Control by www.gmpsop.com
Corrective action
A documented action plan should be developed if any major problems arise
during on internal audit. The action plan should consider the following, as
appropriate:
ATTRIBUTES OF CORRECTIVE ACTIONS
Activities
List any activities that must be accomplished to
either correct the existing problem or eliminate o
potential problem.
If there are multiple activities, a corrective and
preventive action (CAPA) project plan may be
valuable. Assign a person to take responsibility
for implementing the plan to the agreed
timeframe. If the plan is complex, a CAPA team
maybe valuable.
In CAPA activities, it is also important to be
realistic about achievable timeframes and
milestones.
Documents
Implementing a CAPA usually involves a change
to existing practices via the change control
program, as well as the updating of procedures,
instructions and specifications.
It is important to identify which documents will
need to be updated as part of the CAPA plan.
Processes
Either quality system procedures or
manufacturing processes are usually revised
when implementing CAPA.
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