EU GMP Chapter 1: Pharmaceutical Quality System (2013)

Context and history

Chapter 1 is the opening chapter of the EU GMP Guide. It sets out the pharmaceutical quality system that everything else depends on. This version is revision 3, with a deadline of 31 January 2013 for coming into operation. It was amended to align with the concepts and language of ICH Q10, and its title changed to Pharmaceutical Quality System.

Computerised systems sit inside this system: Annex 11 assumes that risk management, change control, deviations and management review already work. A draft revision was published in 2025 to reflect ICH Q9(R1).

Who and what it applies to

Holders of manufacturing authorisations for medicinal products for human and veterinary use. GMP applies from the manufacture of investigational medicinal products onwards, and the size and complexity of a company should be taken into account when designing the system.

What it contains

Principle

The authorisation holder must make medicines fit for their intended use, compliant with their authorisation, and not place patients at risk. This is the responsibility of senior management.

Pharmaceutical quality system (1.1 to 1.7)

What the system must ensure, including product realisation, management responsibilities and continual improvement. Senior management is ultimately responsible, with periodic management review, and the system should be documented.

Good manufacturing practice (1.8)

The basic requirements of GMP for production and quality control.

Quality control (1.9)

Requirements for sampling, testing and release.

Product quality review (1.10 to 1.11)

Regular review of each product to verify consistency and identify improvements.

Quality risk management (1.12 to 1.13)

A systematic process for assessing, controlling, communicating and reviewing risks to quality, based on science and linked to patient protection.

Key points

• Senior management carries ultimate responsibility for an effective quality system.
• Periodic management review is required.
• Product quality review is required regularly.
• Quality risk management underpins the system.
• The level of effort and formality should match the level of risk.

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.

• When defending a computerised system decision, link it back to this chapter: risk, change control and management review.
• Put data integrity and computerised system metrics into management review.
• Scale the system to your size, but keep it documented.

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.