An extremely important part of GMPs is documenting every aspect of manufacturing processes, activities, and operations. You could say that SOPs are the foundation of the GMP framework. The purpose of SOPs is to ensure uniformity in the performance of GMP-related operations to assure safe, quality products that meet their established specifications and minimize the potential of adulteration, contamination and/or mix-ups during manufacturing and distribution. SOPs are usually the first item reviewed in a regulatory inspection, and the Natural Products Association third-party auditors will focus the majority of their audit time on reviewing your SOPs for our GMP certification program. Your SOPs and other GMP-documentation such as records are used by FDA and third-party auditors to see how your company operates and to evaluate your GMP compliance.
Additionally SOPs make good business sense because they tell your employees what they are supposed to do, when and how. They can minimize or eliminate contamination, mix-ups and errors which saves time and other resources, improves efficiency, and results in consistent products that meet their established specifications.