SOPs: Periodic Review AND Process Improvement

The purpose of Standard Operating Procedures (SOPs) is to achieve consistency and uniformity in the way processes are conducted and to ensure that these processes are conducted in a manner compliant with industry and government regulations. Once an SOP is in place, it is equally important to strive for process improvement. Whether called for by changes in regulations or discovery of a “better way,” the process of updating SOPs ultimately contributes to the integrity of a pharmaceutical company and its products.

This is where periodic reviews of SOPs come into play and have a highly significant role. Regulations evolve and change and, therefore, processes must change accordingly. Reviews of SOPs (whether annual, biennial, etc.) are an opportunity to review the most current and updated regulations and incorporate changes to processes as required. It is the periodic reviews of SOPs that ensure continued compliance and contribute to a culture of ensuring patient safety, which should, of course, always be the number one goal.

Apart from regulation-based changes in processes, periodic reviews also provide the opportunity to re-evaluate a current process and seek improvement. Often times in a review of an SOP, people focus on documenting the “current” process. Often one hears much of “this is how we do it.” The question should not just be “what do we do now;” rather, the right question is really “can we do this better.” A current process may be compliant, but there may be ways to streamline it and make it more efficient, allowing the individuals and departments involved to function in a more productive manner.

Periodic reviews of SOPs are all too often viewed as cumbersome. However, they really should be viewed in a positive light as they are an opportunity to not only ensure that a process is correct, but to also determine if the process can be improved. It will always be important to keep informed of the most current regulations and change processes accordingly. However, pharmaceutical and other healthcare companies can remain ahead of the game and have a greater positive impact on patients by exceeding what is merely required by regulations and focusing on process improvement overall.