Need to know about INCIDENTS and CAPA ,?
can any tell with examples with some incidents and CAPA taken for that ?
Incidents are generally small events in the GMP environment. These are usually isolated cases of deviations and do not have severe impact on Quality of products being manufactured. Hence, for such events and elaborate investigation may not be required. And hence a formal CAPA plan is not needed. However, these need to be adequately addressed to ensure compliance, like simple counselling to the person responsible for such incident is enough. For example, incident could be not wearing epron in manufacturing area, missing temperature monitoring in warehouse on a particular day, one time excursion of temperature in storage area etc.
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