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

The purpose of a Standard Operating Procedure (SOP) in Good Manufacturing Practice (GMP) is to provide detailed instructions for ensuring consistency in processes. SOPs serve as formalized documents that outline specific tasks and their methodologies to guarantee that operations are performed in a uniform way across different shifts, teams, and facilities. This consistency in execution is vital in pharmaceutical manufacturing, where variations can lead to deviations, compromising product quality and safety. By adhering to SOPs, organizations can ensure that every aspect of production, quality control, and compliance is maintained according to established protocols.

While SOPs can indirectly support the training of new employees and document certain activities, their primary function is to standardize operations to maintain quality and compliance with regulatory requirements. This precision in following SOPs helps in reducing errors and variability, ensuring that all personnel perform tasks in the same way, which is essential in a highly regulated industry like pharmaceuticals.