About Us

We are a small group of Quality Assurance and Quality Control professionals with real first hand experience of FDA drug and dietary supplement, MHRA, Swiss Medica, and TGA inspections and observations. We realised that whilst help is out there its often very expensive and can teach you nothing that you didn't already know, but you may need a procedure or two quickly to fill a gap that we could with our experience build on and customise. And that's where the idea of GMP SOP Download started to provide an immediate download service.

So we set off in 2014 to write a base set of standard operating procedures (SOPs) using our knowledge of GMP regulations 21 CFR 111, 21 CFR 211, and the Eudralex orange guide and launched on Shopify in 2017 with a primitive website selling these as downloads, which we upgraded in 2023.That website served us well until 2025 where we have relaunched into what you see now, with improved navigation. We hope the experience is enjoyable and easy to use.

We also realised in these inspections that achieving consistency and quality in recording information, from one laboratory analyst to another, in out of specification investigations and laboratory notebooks, was very time consuming and required a lot of effort, so we created report forms to solve that issue also that can be implemented into LIMs systems.

But our principle remains the same. If you have an emergency and you are out of compliance and need some procedures fast then this is the place for you, equally for companies just starting out in understanding the requirements, or if you just want more subject matter to compare with your own then GMP-SOP-Download.com can help you out.

We are now expending on that with compliance news and information that can hopefully become a two way forum.