About Us

We are a small group of Quality Assurance and Quality Control professionals with real hand experience of FDA, MHRA, Swiss Medica, and TGA dietary supplement and pharmaceutical 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 probably had no time for. What we always wanted was to get an existing base procedure 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.

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.

So we set off in 2014 to write a base set of procedures using our knowledge of 21 CFR 111, 21 CFR 211, and the Eudralex orange guide. After some failed attempts with other website providers we stumbled upon Shopify in 2017 and started a primitive website on a low budget selling these as downloads

That website served us well until 2023 where we have relaunched into what you see now, with improved navigation, some industry news that we hope to turn into a forum for compliance specialists, and hopefully a higher presence on google as returning customers were struggling to find us.

But the 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 GMPSOPDownload.com can help you out.

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