EU GMP Chapter 1 revision: Pharmaceutical Quality System (draft)

Context and history

This is a draft consultation document revising EU GMP Chapter 1. It was published on 3 September 2025. The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended it, in order to reflect the changes made by ICH Q9(R1) on quality risk management. It is a draft: the 2013 chapter stays in force.

Who and what it applies to

Holders of manufacturing authorisations. It would replace the current Chapter 1 once final and in operation.

What it contains

Quality risk management

Expanded to reflect ICH Q9(R1): managing subjectivity, and keeping effort, formality and documentation in line with the level of risk.

Risk review

The output of risk management should be reviewed to take account of new knowledge and experience.

Product availability

Adds consideration of risk-based prevention and mitigation of drug shortages, linked to quality and manufacturing risks.

Review timeframes

Allows some review timeframes to be adjusted based on manufacturing considerations.

Key points

• The driver is ICH Q9(R1), not a change of direction.
• Subjectivity in risk assessment should be managed and minimised.
• Formality should match the level of risk.
• Risks to product availability come into view.
• Nothing here applies yet.

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.

• Check that your risk procedures already address subjectivity and formality, as ICH Q9(R1) is in force regardless.
• Do not change procedures for this draft alone.

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.