How to know about CAPA || Corrective And Preventive Action || Pharma Guide ||
How to know about CAPA || Corrective And Preventive Action || Pharma Guide || Corrective action: Action taken to rectify, fix or correct a specific deviation, defect or undesirable situation. Preventive action: Action taken to eliminate the cause of deviation, defect, or other undesirable situation in order to prevent the future occurrence of such or similar an event. Source documents of CAPA are identified as: GMP investigations Deviations Laboratory investigations Internal audit reports External audit reports Customer audit reports Regulatory inspection reports Product failures Complaints Returned goods Incidence reports Source document shall provide the proposed corrective and preventive actions. The proposed corrective and preventive actions shall be approved by QA prior to implementation. The proposed corrective and preventive actions shall be verified during CAPA evaluation in form. The CAPA form shall be treated as a tracking form of corrective and pre...