![]() Where CAPA : prefix of Corrective Action & Preventive Action shall make entry into CAPA register by giving following nomenclature. ![]() which shall be raised & approved by QA Dept. QA supervisor shall list down the recommendation or suggestive Corrective Action or Preventive Action and update the CAPA register (As per given format).On receipt of approved documents (e.g.Plan(s) required overcoming and preventing identified nonconformities. Action Plan: Committed strategies to address corrective actions and /or preventive action.Root cause analysis: To identify the true cause(s) of failure or deviation, to implement corrective actions to immediately eliminate failures or deviations and implement preventive actions to prevent re-occurrence.Effectiveness Monitoring: Process for post implementation of CAPA outcome to conform the adequacy & sustainability of the steps taken to correct & prevent deficiency.Preventive Action: Action taken to eliminate the cause of a potential nonconformity, defect or other undesirable situation, in order to prevent occurrence. ![]() Corrective Action: Action to eliminate cause of non conformity, defect or other undesirable situation, in order to prevent recurrence. ![]() Management Reviews and other sources of quality data/trends.Ĭoncerned Dept., Concerned Dept.Deviations, Event & incident investigation.This SOP is applicable for all Corrective Actions and Preventive Actions (CAPA) initiated for following GxP systems, processes and records, but not limited to… To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |