Three-Part Structure of SOPs

Just as buildings are held together by a sound structure, complex documents like Standard Operating Procedures (SOPs) also rely on a clear, logical framework. To write high-quality SOPs, it helps to understand their underlying structure.

While the FDA and other regulatory bodies don’t prescribe a fixed format for SOPs, most SOPs—regardless of their purpose, subject, or audience—follow a common three-part structure:

Part 1: Front Matter
Part 2: Body
Part 3: Back Matter

The figure below shows the typical elements found in each of these sections.

Is this structure set in stone? Not at all. Some sections may not apply to every SOP, and different organizations often adapt this framework to suit their needs.

Once you grasp how these three major parts work together—and how their smaller pieces fit inside each one—you’ll find it much easier to write, review, and understand any SOP. Knowing the structure brings clarity to the complexity.

The whole is more than the sum of its parts.

ARISTOTLE