How to Write an SOP

Free template and examples

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They may seem simple, but SOPs (standard operating procedures) are surprisingly tricky. On the surface, they describe how a specific process is carried out at your organization. Pretty straightforward, right?

In reality, there are a lot of requirements for writing a good SOP, and auditors have a sharp eye out for any missing components and unclear steps.

Here’s what you need to know to write GxP-compliant SOPs—plus a free SOP template and examples you can use to get started.

What’s the purpose of an SOP?

An SOP has one main job: To clearly define how your team executes a process so that anyone reading it knows exactly what happens, who does it, and when. An SOP takes a repeatable process and makes sure it gets carried out the same way every time.

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Writing SOPs

Having written 100's of SOP, procedures and policies over the years I find it very helpful to create a process flow diagram first. I'll label each step with a number that can be used in text descriptions, and I put an owner in the step. This all helps the user understand the process, making sure there isn't a missing step or too many steps. I will put this in the process description the add where necessary any detail not in the flow diagram. This is also the "picture" that's worth a 1000 words. It helps the user understand the steps their order and ownership.

The other thing I do is create a separate Definitions & Acronyms document. Too many times a definition is used in multiple documents, and the definition is different.