EudraLex - Volume 4 - GMP guidelines

The European Commission is undertaking a significant revision of EU GMP Chapter 1: Pharmaceutical Quality System, with public consultation closing on December 3, 2025, and a proposed implementation in late 2025. This update, led by the EMA GMDP-Inspectors Working Group in cooperation with PIC/S, will align the chapter with ICH Q9(R1) (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System), emphasizing a proactive, evidence-based, and risk-focused approach to quality. Key changes include greater emphasis on risk management, knowledge management, supply chain integrity, and the integration of GMP principles throughout the entire product lifecycle, from development to discontinuation.

he European Commission is undertaking a significant revision of EU GMP Chapter 1: Pharmaceutical Quality System, with public consultation closing on December 3, 2025, and a proposed implementation in late 2025. This update, led by the EMA GMDP-Inspectors Working Group in cooperation with PIC/S, will align the chapter with ICH Q9(R1) (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System), emphasizing a proactive, evidence-based, and risk-focused approach to quality. Key changes include greater emphasis on risk management, knowledge management, supply chain integrity, and the integration of GMP principles throughout the entire product lifecycle, from development to discontinuation.

Key Aspects of the Revision

• Quality Risk Management (QRM):

  The revision integrates ICH Q9(R1) to foster a more proactive, science-driven, and formal approach to risk management. This includes:

  • Proactive identification of manufacturing risks to prevent shortages and mitigate supply chain vulnerabilities.

  • Application of QRM during the design and validation of control systems.

  • Consideration of subjectivity in risk assessment.

• Knowledge Management (KM):

  A greater emphasis is placed on managing product and process knowledge throughout the product lifecycle.

• Product Lifecycle:

  The update moves beyond a focus solely on manufacturing to encompass GMP principles across the entire lifecycle, including development, technology transfer, and product discontinuation.

• Proactive Quality Culture:

  The revision aims to shift from a reactive, procedure-based model to a more dynamic system that promotes a proactive, evidence-based quality culture.

• Supply Chain Focus:

  There is an enhanced emphasis on controlling suppliers, the supply chain, and outsourced activities, addressing concerns highlighted by complex global supply chains.

• Scientific Rationale:

  The revision stresses the importance of scientific justification in risk assessment and decision-making.

Why the Revision Is Necessary

• Alignment with ICH Guidelines:

  The revision aligns EU GMP with the globally recognized ICH Q10 guideline on Pharmaceutical Quality Systems and the recently updated ICH Q9(R1) on Quality Risk Management.

• Addressing Supply Chain Vulnerabilities:

  The update aims to make pharmaceutical supply chains more robust by focusing on proactive risk identification and mitigation.

• Global Harmonization:

  The changes promote global alignment of GMP expectations, fostering greater consistency in quality standards worldwide.

• Public Health Protection:

  By fostering a stronger, risk-based quality system, the revision aims to ensure the continuous supply of safe, effective, and reliable medicines to patients.

Next Steps

• Public Consultation:

  The European Commission is currently seeking public and stakeholder input, with the deadline for comments being December 3, 2025.

• Implementation:

  Once finalized, the revised Chapter 1 will represent a significant update to the EU's GMP requirements for pharmaceutical manufacturers.