Certified Pharmaceutical GMP Professional Practice

What is the primary purpose of a Standard Operating Procedure (SOP)?

1. To create detailed product specifications

2. To standardize operations and reduce deviations

3. To record employee attendance

4. To develop new marketing strategies

The correct answer is: To standardize operations and reduce deviations

The primary purpose of a Standard Operating Procedure (SOP) is to standardize operations and reduce deviations. By providing a clear and consistent framework for procedures, SOPs help ensure that all personnel follow the same methods and practices, which contributes to achieving reliable and reproducible results. This is especially critical in pharmaceutical manufacturing and other regulated environments where consistency is vital for quality assurance and compliance with Good Manufacturing Practices (GMP). SOPs serve as essential tools in training employees, guiding them through processes step by step, thereby minimizing the risk of errors that could lead to product quality issues or regulatory non-compliance. By reducing variability in operations, SOPs contribute to overall product safety and efficacy, ensuring that all actions taken during manufacturing processes align with established regulatory standards and company policies. The other options do not align with the primary aim of an SOP. While detailed product specifications are important for product development, they are not the focus of SOPs. Recording employee attendance is a human resources function that typically falls under different procedures. Developing new marketing strategies is unrelated to the operational standardization intended by SOPs.