1.
CAPA
Corrective
Action:Action taken to eliminate the causes of an existing
Non-Conformity, defect or other undesirable situations to prevent recurrence corrective action is a reaction to a problem
that has already occurred. It assumes that a nonconformance or problem exists
and has been reported by either internal or external sources. The actions
initiated are intended to: Fix the problem and modify the quality system so
that the process that caused it is monitored to prevent a recurrence. The
documentation for a corrective action provides evidence that the problem was
recognized, corrected, and proper controls installed to make sure that it does
not happen again.
Preventive
Action: Action taken to eliminate the causes of potential
non-conformity, defect or the undesirable situations to prevent occurrence. A
preventive action is initiated to stop a potential problem from occurring. It
assumes that adequate monitoring and controls are in place in the quality
system to assure that potential problems are identified and eliminated before
they happen. If something in the quality system indicates that a possible
problem is or may develop, a preventive action must be implemented to avert and
then eliminate the potential situation. The documentation for a preventive
action provides evidence that an effective quality system has been implemented
that is able to anticipate, identify and eliminate potential problems.
Assignee:
The
person assigned action for a CAPA .
Corrective Actions as well as Preventive Actions are the ways to mitigate risk
to the product, process, equipment or
facilities. In order to develop the proper Corrective Actions and Preventive
Actions (CAPA ) system it is
desirable that risk associated to the process, product, equipment or facilities
are understood and appropriate actions are initiated.
Corrective Actions and
Preventive Actions (CAPA ) shall be
applied throughout the life cycle of the product.
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Pharmaceutical guideline only