EU GMP Annex 15: Qualification and Validation

Context and history

Annex 15 sets out the EU's principles for qualifying and validating facilities, equipment, utilities and processes. It was first published in 2001, and this revision came into operation on 1 October 2015 to reflect changes in manufacturing and regulation, including ICH Q8 to Q11, Annex 11 and newer process validation thinking.

It is not a computerised systems document, but it is linked: computerised systems often control the equipment and processes it covers, and the FDA and PIC/S have comparable expectations. PIC/S PI 006-4 is a related document, and a concept paper on revising Annex 15 is listed by PIC/S.

Who and what it applies to

Facilities, equipment, utilities and processes used to make medicinal products. It may also be used as optional supplementary guidance for active substances.

What it contains

Principle

Sets the scope, and links qualification and validation to the product lifecycle and risk.

1. Organising and planning

Validation master plan or equivalent, and a risk management approach.

2. Documentation

Good documentation, protocols, reports and handling of changes.

3. Qualification stages

User requirements, design qualification, factory and site acceptance tests, installation, operational and performance qualification.

4. Re-qualification

Periodic evaluation to confirm a state of control.

5. Process validation

Traditional, continuous and hybrid approaches, and continued process verification.

6. Verification of transportation

Transport conditions and their monitoring.

7. Validation of packaging

Primary packaging equipment.

8. Qualification of utilities

Steam, water, air and other utilities.

9. Validation of test methods

Analytical test methods.

10. Cleaning validation

Demonstrating effective cleaning.

11. Change control

Control of planned changes.

Key points

• Validation is a lifecycle activity tied to risk.
• Qualification follows stages from user requirements to performance qualification.
• Requalification is periodic.
• Process validation has more than one accepted approach.
• Change control applies throughout.

In practice

General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.

• Align validation for equipment and its controlling software, so the two do not leave gaps between them.
• Use the same risk approach across Annex 15 and Annex 11.

Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.