Good Manufacturing Practices Audit Checklist

This document is a checklist designed to assist in conducting a Good Manufacturing Practices (GMP) audit to assess compliance with GMP regulations. It outlines various sections that auditors must review, including facility and equipment conditions, documentation and records, personnel hygiene, quality control measures, vendor and supplier control, production and process controls, sanitation and cleaning procedures, product recall and withdrawal protocols, training and education requirements, complaint handling processes, and regulatory compliance. Each section includes specific items that auditors must verify, such as the cleanliness of the facility, maintenance records for equipment, written procedures for GMP-related activities, and training documentation for personnel. Observations and corrective actions can be noted in the designated areas, ensuring that any issues identified during the audit are documented and addressed appropriately.