Certified Pharmaceutical GMP Professional Practice

What should a laboratory have to evaluate lab controls effectively?

1. A list of social events

2. A master file of specifications for all raw materials

3. A summary of employee performance

4. An inventory of office supplies

The correct answer is: A master file of specifications for all raw materials

To effectively evaluate lab controls, a laboratory should maintain a master file of specifications for all raw materials. This documentation serves as a critical reference that contains information regarding the quality attributes, standards, and acceptance criteria for each raw material used in the lab. Having this master file enables the laboratory to conduct evaluations based on established specifications, ensuring compliance with regulatory requirements and the integrity of the testing process. This information is essential for assessing whether incoming raw materials meet predetermined quality standards, which plays a vital role in maintaining the overall quality and safety of the pharmaceutical products being developed or tested. Without a master file, evaluating whether lab controls are effective would be challenging, as it would lack a basis for comparing actual performance against quality standards. In contrast, the other options such as a list of social events, a summary of employee performance, or an inventory of office supplies do not directly contribute to the evaluation of lab controls or the quality assessment of lab processes. They serve different purposes and do not provide the necessary framework or criteria needed for the effective evaluation of laboratory operations.