RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES AS PER REGULATORY REQUIREMENTS 1. PROBLEM IDENTIFICATION What Happens Clearly define the deviation,…
Why investigation? To identified error Random error Impacts precision (Weight error dilution error injection to injection error Example document error, document error…
Wet Lab analyst do Error ! Wet lab analyst are forgot a taken out of LOD or sulphated Ash, weight…
DIN (documents incident) IncidentDeviationOOS DIN Documentary error like miss date and sign, entry missed in logbook, Incident Like power failure,…