The European Commission has announced a targeted revision to Chapter 1 of EudraLex Volume 4, the EU Good Manufacturing Practice (GMP) Guidelines, focusing on the Pharmaceutical Quality System (PQS). This update, developed collaboratively by the European Medicines Agency's (EMA) Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP-IWG) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), aims to align the guidelines with contemporary advancements in regulatory science and risk management principles.
The primary objective of the revision is to enhance the efficiency of regulatory frameworks by incorporating evidence-based approaches, including the recently updated ICH Q9(R1) guideline on Quality Risk Management It places greater emphasis on knowledge management (KM) and fostering a proactive quality culture within pharmaceutical manufacturing operations. These changes build on the existing foundation of Chapter 1, which already mandates that a PQS must manage product and process knowledge across all lifecycle stages, ensuring compliance with modern GMP expectations.
A key aspect of the revision is its integration with ICH Q10, the guideline on Pharmaceutical Quality Systems. KM and QRM are positioned as essential enablers for an effective PQS.
Notably, a new paragraph (1.4(xviii)) introduces the application of KM in conjunction with QRM to create an early warning system for identifying and addressing emerging quality and manufacturing risks.
Additionally, paragraph 1.13 underscores the role of knowledge in driving informed decision-making, prompting re-evaluations, and promoting continuous improvement
The proposed amendments address three core areas: Quality Risk Management (QRM), Knowledge Management (KM), and Product Quality Review (PQR)
For QRM, the revision incorporates ICH Q9(R1) through seven new sections that promote risk-based decision-making, a proactive and evidence-based quality culture, scientific rationale in risk assessments, appropriate formality in QRM processes, awareness of subjectivity in evaluations, and the proactive identification of manufacturing risks to prevent shortages and strengthen supply chain resilience.
KM is elevated as a foundational element in GMP-regulated environments, working synergistically with QRM to improve oversight and risk mitigation
. Regarding PQR, the updates provide clearer requirements, such as incorporating trending data from prior reviews for products with limited batch production in a 12-month period, specifying minimum content for PQRs when no batches are manufactured, and permitting adjusted review timelines with proper justification.
### Key Takeaways
- **Consultation Deadline:** Comments on the revised draft must be submitted by December 3, 2025.
- **Core Focus Areas:** The revision targets enhancements in Quality Risk Management (QRM), Knowledge Management (KM), and Product Quality Review (PQR).
- **Integration with ICH Guidelines:** Aligns with ICH Q9(R1) for QRM and ICH Q10 for PQS, emphasizing KM and QRM as enablers for proactive risk oversight.
- **New Provisions:** Includes an early warning system via KM and QRM (paragraph 1.4(xviii)) and the use of knowledge for decision-making and improvement (paragraph 1.13).
- **PQR Clarifications:** Requires trending data from previous reviews for low-volume products, minimum content for zero-batch periods, and justified adjustments to review timelines.
- **Development Collaboration:** Joint effort by EMA GMDP-IWG and PIC/S to ensure science-based, risk-managed regulatory frameworks.
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