Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1

Public health stakeholders involved in GMP activities.

The organisations representing stakeholders involved in GMP activities are encouraged to take part in the consultation and to receive all the comments of this consultation from their members, to compile and send the comments via the EU Survey tool.

The update of Chapter 1 of the Good Manufacturing Practice (GMP) guidelines is necessary to establish efficient regulatory frameworks based on good science and risk management. 

This revision aligns GMP requirements with international best practices and adapts them to industry advancements, ensuring both the availability and the quality of medicines.

To maintain the global alignment of standards, this document has been revised by the EMA GMDP-Inspectors Working Group in cooperation with the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

• More information on EudraLex - Volume 4 - GMP guidelines

Revision of Chapter 1 - Pharmaceutical Quality System

The revised Chapter 1 reflects the updated ICH guideline on Quality Risk Management, ICH Q9(R1), strengthening knowledge management and risk management across the product lifecycle. 

Alignment with ICH Q9(R1) fosters a proactive, evidence-based culture that reduces variability in quality outcomes. By embedding risk-based decision-making and emphasising scientific rationale and proportionality in risk assessment, it ensures consistent product quality and availability. 

The revision also stresses the importance of proactive identification of manufacturing risks to prevent shortages and mitigate supply chain vulnerabilities, thereby safeguarding patient safety and public health.

The guideline also clarifies requirements for product quality review, particularly regarding product grouping and situations where only a limited number of batches were manufactured during the review period.

• Download the draft guidelines:  Revised Chapter 1 - Pharmaceutical Quality System