What is a correct duty of the Qualified Person (QP) responsible for batch release?

The correct duty of the Qualified Person (QP) responsible for batch release is to confirm the quality of medicinal products in accordance with the requirements of the Marketing Authorisation. The QP plays a critical role in ensuring that each batch of a medicinal product meets the necessary quality standards and complies with regulatory requirements before it is released for sale or supply. This involves thorough assessments of the manufacturing process, quality control testing results, and adherence to good manufacturing practices (GMP) as mandated by the relevant regulatory authorities.

This duty is fundamental because it guarantees that patients receive safe, effective, and high-quality medicines. It emphasizes the responsibility of the QP to act in the interest of public health by ensuring that only compliant and properly tested products enter the market.

The other options do not accurately represent the primary role of the QP. For example, while signing off on marketing materials is important, it is not a central responsibility of the QP. Similarly, overseeing the clinical trial process and managing regulatory submissions involve different roles typically assigned to clinical research or regulatory affairs professionals, not the QP.