Forms 483 and Warning Letters cite inadequate standard operating procedures (SOPs) as one of the most frequent causes of many deficiencies and observations. While specific SOP issues can often be blamed on lack of communication, monitoring, and/or enforcement, poorly written SOPs can quickly grow into many other major compliance problems.
A well written SOP offers clear direction and instruction specifically designed to avoid deviations: an absolute requirement for maintaining compliance and delivering quality products.
Standard operating procedures are written, step-by-step instructions that describe how to perform a routine activity. Employees should complete them in the exact same way every time so that the business can remain consistent. Standard operating procedures help prevent product adulteration. In the Dietary Supplement world these would apply to:
A standing operating procedure should never be difficult to read or vaguely worded. It should be brief, easy to understand and contain actions steps that are simple follow. A good standard operating procedure should clearly outline the steps and inform the employee of how to perform a task.
We can help write, maintain and train on your SOPs. Please Contact Us Today!