At the last internal audit, a regulatory affairs professional identified a need for a corrective action for the manufacturing process. Which of the following stakeholders should be notified FIRST?

Notifying quality assurance first is essential because this team is primarily responsible for ensuring that all processes adhere to the regulatory requirements and internal standards. Quality assurance personnel are directly involved in overseeing the manufacturing process and can take immediate actions to evaluate and rectify any issues identified during the internal audit.

When a corrective action is needed, quality assurance can assess the situation, investigate the root cause of the issue, and implement measures to mitigate any risks associated with the manufacturing process. They play a vital role in maintaining compliance and ensuring that product quality is not compromised throughout the manufacturing cycle.

In contrast, while the other stakeholders have important roles, they are typically not the first to be notified in matters concerning immediate corrective actions related to the manufacturing process. For example, the quality improvement team may focus more on long-term process enhancements rather than immediate corrective measures. Clinical affairs may not be involved until the product is ready for use or requires clinical evaluation, and a regulatory agency would generally be notified later, particularly when reporting is necessary following internal compliance investigations or when regulatory actions are required.