Certified Pharmaceutical GMP Professional Practice

Which output is expected from a quality risk management process?

1. Increased product pricing

2. Documentation and implementation

3. Reduction in regulatory compliance

4. Higher employee turnover rates

The correct answer is: Documentation and implementation

A quality risk management process is designed to ensure that risks related to product quality are systematically identified, assessed, and mitigated. This process results in comprehensive documentation that outlines the identified risks, the rationale for the decisions made, and the management strategies implemented to address these risks. The proper documentation ensures that there is a clear record of the risk management activities, which is vital for both internal quality assurance and external regulatory compliance. Additionally, effective implementation of these measures helps in maintaining product quality, enhancing patient safety, and ensuring that products meet regulatory requirements. Other potential outputs, such as increased product pricing or higher employee turnover rates, are not direct expectations of a quality risk management process. Instead, such processes aim at maintaining product integrity and compliance, rather than increasing costs or negatively impacting workforce stability. Therefore, the expected output primarily revolves around thorough documentation and subsequent implementation of risk management strategies.