Do you expect inspection from FDA, EMA, MHRA and PIC/S? Regulatory inspections can be a source of stress and uncertainty for many organizations. However, by understanding and preparing for these inspections, you can turn them into opportunities to demonstrate your commitment to quality and compliance.
The FDA, EMA, MHRA, and PIC/S are increasingly harmonizing their inspection processes and expectations, reducing differences and simplifying preparation for organizations operating in multiple regions. Regulatory authorities are increasingly emphasizing Quality Culture and Quality Management Maturity during inspections, recognizing their importance for ensuring product safety and efficacy.
Quality Culture is the shared values and practices that reflect an organization’s commitment to quality. It involves prioritizing quality at all levels, promoting proactive problem-solving, continuous improvement, and open communication about quality issues. Quality Management Maturity entails developing and implementing advanced quality management practices. It reflects an organization’s progression from basic compliance to an integrated approach characterized by well-defined processes, effective risk management, and data-driven continuous improvement.
Organizations should prioritize Quality Culture and Quality Management Maturity in their preparation efforts. This approach not only meets regulatory expectations but also enhances operational efficiencyand product quality.
Together we can assess your current inspection readiness state, and improve if needed. In this case early cooperation is in your advantage!