Certified Pharmaceutical GMP Professional Practice

What is a required SOP related to laboratory operations?

1. Employee scheduling

2. Stability testing

3. Supplier assessment

4. Marketing communications

The correct answer is: Stability testing

The choice of stability testing as a required Standard Operating Procedure (SOP) related to laboratory operations is correct because stability testing is a critical component of the pharmaceutical development process. This SOP outlines the procedures for conducting tests that assess how the quality of a drug substance or product varies with time under the influence of environmental factors such as temperature, humidity, and light. Stability testing is essential to determine the expiration date and ensure that the product remains effective and safe for patients throughout its shelf life. Establishing an SOP for stability testing is vital for regulatory compliance, as agencies like the FDA and ICH require evidence that the product maintains its intended quality characteristics over time. This SOP guides laboratory personnel on the necessary methods, equipment, and data analysis needed to perform these tests accurately and consistently. In contrast, the other options—employee scheduling, supplier assessment, and marketing communications—are not specifically focused on laboratory operations. They pertain to different areas of business management or regulatory compliance but do not play a direct role in laboratory practice related to the quality control and assurance processes inherent in pharmaceutical manufacturing and testing.