GMP SOP Download

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 do not charge any annual, membership or subscription fees now or in the future. We are providing an immediate availability service on-line with a one time cost.

In return we ask you to make a company specific purchase and re-purchase if the procedure or report form is to be used at a second company. As discussed in our privacy policy we may use watermark encryption technology to monitor this.

Our website and payments are hosted by Shopify who provide the latest 3D secure authentication, fraud protection and SSL encryption technology on servers based in the USA and Canada. As with all internet transactions the transmission of data at the point you enter it via shared wi-fi is often the weakest point and we advise you to always use anti-virus software and a secure VPN connection for any internet purchase, not just for our site.

Debit and credit card payments hosted by Shopify, Paypal and Paypal Credit, and in some countries pay in instalments by Klarna

Shopify use geolocation technology to offer prices on the website in your local currency, but depending upon which country you are from, you may be able to make changes to currency options in the top right hand corner of the home page

After you have successfully completed payment in the shopping cart you will receive an e-mail from us, to the address that you entered, which contains a download link which you can use immediately. This link will not expire and can be used again on the same computer should you lose or delete part of the documents

You are responsible for providing a PC or laptop, with access to the e-mail address used for your purchase, with a licensed version of Microsoft Word to download, save, read, and edit your files.

Check that the e-mail address that you entered during checkout is correct, if not then contact us with the correct one. If it is correct check your spam or junk folders, and firewall settings and allow e-mails to be received from info@gmpsopdownload.com

Very occasionally, Shopify or Paypal will hold payment if they suspect fraud, or if personal details do not match their records. Also check that payment has fully completed which will release the download e-mail.

Please always e-mail us first to info@gmpsopdownload.com and we will try to settle this amicably with you. Chargebacks can be expensive for you and for us. Shopify are able to provide full history of the transaction to the banks.

This is fortunately very rare however due to the nature of downloads we cannot offer a refund. We always suggest to purchase one, or a small number of, procedures from us first as an inexpensive example to see if you are happy with our products.

If you see something you disagree with, or you don't like that format, then please do amend it, the procedures are fully editable. If you have a related regulatory observation please do contact us so we can consider amendments. Everyone involved in compliance is continually learning and the focus, opinions, and expectations of regulatory authorities does evolve constantly. We may be able to offer you a discount on your next purchase if you share these instances and the details with us.

Within the business you have purchased them for yes, they are intended to be used as part of your QMS edited or unedited. However, external partners and other companies must purchase their own version in accordance with the Terms and Conditions (one purchase per company physically using the procedure).

As you can appreciate we are a small business and have put a lot of effort into the service and user experience and we rely on your good faith. We reserve the right to use watermark encryption technology for breaches of our Terms and Conditions of use.

All SOPs and report forms are in English although we are hoping to offer soon automated translations in other languages using apps.

All documents are in Microsoft Word format, but you are responsible for providing a licensed copy of Microsoft Office or Word software to use these.