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