The three main reasons why GMP auditing is so important include the:

• Safety Aspect
• Business Aspect
• Regulatory Compliance Aspects

Safety Aspects

• Assurance of quality for the patient’s safety
• Minimizing the potential risk of temporary or permanent injury for the operator
• Minimizing any potential hazards to people outside the facility

Business Aspects

• Increased throughput
• Reductions in rejections and reworks
• Reduction in utility costs
• Avoidance of capital expenditures
• Fewer complaints about process related failures

Regulatory Compliance Aspects

• Meeting regulatory requirements
• Verifying cGMP compliance and observance to all requirements to permit the listing of the audited organization as an approved establishment
• Providing the auditee with an opportunity to advance the quality system