API MANUFACTURING FACILITY GMP AUDITS / GENERAL FINDINGS-1

Regarding to Quality Management System

"Product Quality Review" not having at least one of below evaluation parameters;

-Starting Material Evaluation (including CPk calculation of analysis results)

-Finished Product Evaluation (including CPk calculation of analysis results)

-In-Process Controls

-Out-of-Specifications

-Deviations

-Changes and Variations

-Stability Evaluation

-Recalls/Returns/Complaints

-Corrective and Preventative Actions

-Validations/Qualifications

-Contract Agreements