PREPARATION AND CONDUCTION OF GMP AUDIT INSPECTION BY REGULATORY AUTHORITY OR CUSTOMER

Description

GMP audits, conducted by regulatory authorities or customers, are crucial for ensuring pharmaceutical quality and compliance. Preparation involves reviewing GMP regulations and internal procedures, conducting mock audits, and addressing identified gaps. During the audit, inspectors assess documentation, interview personnel, and observe operations. Findings are documented and discussed, leading to corrective action plans. Successful audits demonstrate adherence to GMP standards and enhance product quality and safety.