A robust Quality Management System (QMS) is the backbone of GMP compliance and sustained regulatory success. ICH Q10 describes a pharmaceutical QMS that, when implemented, can enhance product quality, reduce variation, and support a culture of continuous improvement. RBridge Lifesciences supports the design, implementation, and review of QMS frameworks for pharmaceutical manufacturers.
What We Offer
- QMS Design and Implementation (ICH Q10 aligned)
- SOP Development and Review
- Change Control System Design
- Deviation and CAPA Management System Setup
- Document Management System Design
- QMS Audits and Gap Assessments
- Training Programme Development
Key QMS Elements
- Process Performance and Product Quality Monitoring
- Corrective Action and Preventive Action (CAPA) systems
- Change Management aligned with ICH Q10
- Management Review and Quality Culture development
- Risk Management integrated with ICH Q9
- Continuous improvement mechanisms