CRITICAL FINDINGS FACED DURING API AUDITS-1

Equipment Cleaning Validation Implementations

-Missing cleaning parameters in the cleaning process like mixing time, rinsing time, temperature, cleaning agent amount
-Not using appropriate cleaning agent for the apolar structered APIs and ingredients
-Insufficient number of cleaning samples
-Missing or inappropriate calculation of residue limits
-Not evaluating microbial residues
-Not evaluating Dirty and Clean Hold Time
-Not considering chemical residues for Dirty Hold Time Study