#1 Who's afraid of Annex 11?

Who’s Afraid of Annex 11?

Part One

This series will explore the subtopics related to the requirements set by the EMA – the European Medicines Agency, which is responsible for publishing Annex 11. Annex 11 outlines the #GMP requirements for computerized systems and forms part of the European regulations governing quality management in the pharmaceutical industry.

These are not “recommendations” – they are mandatory requirements that every pharmaceutical manufacturer operating under EU GMP must comply with, ensuring that computerized systems meet the standards of quality, safety, and process control.

In my previous post, some people commented: “It’s just a guideline,” “It’s not really mandatory,” or “It’s more of a recommendation.” So, I’m attaching an image that best illustrates my perspective on this. But regardless of the debate around what’s mandatory or not – let’s start by understanding what is actually expected of us, before a new revision of the document is released.

Let’s read the opening of Annex 11 together:

“This annex applies to all forms of computerized systems used as part of GMP-regulated activities. A computerized system is a set of software and hardware components which together fulfill certain functionalities. The application should be validated; IT infrastructure should be qualified. Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.”

This paragraph alone could fill five posts 😄 – but let’s keep it short.

Bottom line: If a computerized system is used within a GMP-regulated process – the system must be validated, and the IT infrastructure must be qualified. Black and white, no ambiguity.

Why? Because when a system replaces a manual process, it directly affects process control – and therefore, product quality. Under no circumstances should the system compromise product quality, process control, or quality assurance. Nor should it increase the overall process risk.

And if the system doesn’t replace a manual process? I think the answer is quite clear… 😉 I’d love to hear your thoughts in the comments.

Annex 11 also defines what a “computerized system” is: Any combination of hardware and software components working together to perform a specific function. If that function impacts product quality, process control, or quality assurance – the system requires validation. Whether you call it #CSV or #CSA – the principle is the same.

Does the opening explain how to perform the validation? No. But anyone reading it realizes that it immediately raises dozens of questions – and the EMA tries to address them all within just five pages of fine distinctions.

So next time someone asks you:

“Do we really need to validate this system?”

What will your answer be?