Revision of EU-GMP Chapter 1 planned with Consultation Phase

The EU Commission has published a Stakeholders' Consultation for a revised Chapter 1 of EudraLex Volume 4 - Good Manufacturing Practice Guidelines. The deadline for comments is 3 December 2025.

According to the announcement, the update of Chapter 1 "is necessary to establish efficient regulatory frameworks based on good science and risk management". It has been revised by the EMA GMDP-Inspectors Working Group in co-operation with the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The planned changes relate to three areas:

Quality Risk Management (QRM)

The revised Chapter 1 primarily reflects the updated ICH guideline on Quality Risk Management, ICH Q9(R1), reinforcing both knowledge management and risk management. Seven new paragraphs/ sections are to be added, incorporating key principles such as:

• Risk-based decision-making throughout the product lifecycle
• A proactive, evidence-based quality culture
• Emphasis on scientific rationale in risk assessment
• An appropriate level of formality in QRM processes
• Consideration of subjectivity in risk assessments and QRM results
• Proactive identification of manufacturing risks to prevent shortages and mitigate supply chain vulnerabilities

Knowledge Management (KM)

Knowledge Management is increasingly recognised as a critical pillar in GMP-regulated areas of the pharmaceutical industry. ICH Q10 (Pharmaceutical Quality System) identifies KM, alongside QRM, as a key "enabler" of an effective quality system. Chapter 1 of the EU-GMP Guidelines already states that a PQS should ensure "product and process knowledge is managed throughout all lifecycle stages," highlighting that KM is not merely a theoretical concept but an expected element of modern GMP operations.

Now, in a new paragraph 1.4(xviii), it is emphasised that Knowledge Management should be applied together with QRM "to provide an early warning system that supports effective oversight and response to evolving quality/manufacturing risks." In addition, a new paragraph 1.13 specifies that "knowledge should be used to make informed decisions, trigger re-evaluations, and stimulate continual improvement."

Product Quality Review (PQR)

The revised chapter also clarifies requirements for the Product Quality Review (PQR), particularly regarding product grouping and situations where only a limited number of batches are manufactured during the review period:

• Trending data from the previous PQR should be included when only a few batches of a product were manufactured in a 12-month review period.
• A minimum content for a PQR is defined for cases where no batches of a product were manufactured during the 12-month review.
• Review timeframes may be adjusted appropriately with adequate justification.