In 2024, the pharmaceutical industry is preparing for new ICH Q9 guidelines on quality risk management. By 2025, there will be a higher demand for Quality Risk Managers and QA Specialists. Companies like pharmaceutical manufacturers and biotech firms will need these experts to meet the new standards and improve their risk management. A report by Cpl Life Sciences discusses these trends and the expected impact on staffing needs.
The updated ICH Q9 guidelines for Quality Risk Management (QRM) in the pharmaceutical industry bring several key changes. They provide clearer instructions for making risk-based decisions, focus on managing risks that could affect product supply, and clarify the right level of formality for different risks. The guidelines also align better with other ICH quality standards and promote objective risk assessments to reduce defects and prevent drug shortages. These updates aim to improve consistency, risk management, and regulatory compliance.
Cpl Life Sciences have identified 4 key areas that could emerge or see an increase in demand due to the updated ICH Q9 guidance on quality risk management:
Quality Risk Managers
Quality Assurance Specialists
Compliance Officers
Risk Management Analysts
In the UK pharmaceutical industry, having enough Quality Risk Managers, Quality Assurance Specialists, Compliance Officers, and Risk Management Analysts is crucial. These roles help identify and manage risks, maintain product quality, and ensure compliance with regulations. Proper staffing in these areas prevents costly issues like recalls and supports continuous improvement. This not only protects patient safety but also strengthens the company’s reputation in the competitive market.
We understand that industry leaders such as AstraZeneca, GSK and Pfizer will be looking to bolster their teams in these areas moving into 2025, industry reports suggest a potential increase of around 10-15% in these roles due to the updated ICH Q9 guidelines and other industry trends.
Finally, from our report, Cpl Life Sciences have found that the updates ICH Q9 guidelines will significantly impact the pharmaceutical industry in the UK. We have explored what the major players will be doing. Also, we have seen what the statistics and industry reports state with regard to growth. Overall, this will help to ensure compliance, boost product quality and protect patient safety.
In our next article, we’ll discuss how these changes will impact the biotech industry.
For the full report click here