Pharmaceutical Batch Failure Analysis

Batch Information

Product Name Batch Number Manufacturing Date Expiry Date Reported By Date of Report

Failure Description

Type of Failure Description Date of Occurrence Location (e.g., Production Area, Warehouse)

Initial Investigation

Details Personnel Involved Samples Collected

Root Cause Analysis

Method Used Description of Investigation

Impact Assessment

Product Impact Risk Assessment

Corrective & Preventive Actions

Corrective Action(s) Preventive Action(s) Responsible Person(s) Target Completion Date

Review & Approval

Reviewed By Review Date Approval By Approval Date