Certified Pharmaceutical GMP Professional Practice

Quality risk management is primarily concerned with what aspect?

1. Reducing overall production costs

2. Assessment and control of risks affecting product quality

3. Enhancing employee morale and motivation

4. Increasing market share of pharmaceutical products

The correct answer is: Assessment and control of risks affecting product quality

Quality risk management focuses on the assessment and control of risks that could negatively impact product quality. In the context of pharmaceutical manufacturing, maintaining the integrity, safety, and efficacy of products is paramount. This approach involves identifying potential risks in processes, systems, or materials that could hinder product quality and then implementing strategies to mitigate those risks. Effective quality risk management helps organizations prioritize their resources towards the most significant threats to product quality, ensuring compliance with regulatory requirements and enhancing overall product reliability. This is particularly critical in the pharmaceutical industry, where the stakes involve patient safety and regulatory adherence. While reducing production costs, enhancing employee morale, or increasing market share can be important business objectives, they do not capture the essence of what quality risk management aims to address. The core of quality risk management is to ensure that risks associated with product quality are systematically identified and controlled to protect both the manufacturer and the end-user.