Strengthening Group Quality Governance for GMP & Compliance ExcellenceSihuan Pharmaceutical Group, Multi-site Quality System Enhancement (China, Pharma & Biotech)
Information
Sihuan Pharmaceutical Holdings Group is a leading Chinese pharmaceutical enterprise specializing in cardio-cerebral vascular therapeutics, with strong R&D, production, and marketing capabilities. The group oversees multiple GMP-certified production companies and is committed to quality and safety in line with global standards.
Eddso provided a comprehensive quality interim support program to unify group-wide compliance systems, enhance GMP and FDA audit preparedness, and strengthen EHS governance.
Background
The project facilitated quality visibility, accountability, and audit alignment across diverse manufacturing sites.
- Decentralized Quality Systems
Quality management structures varied significantly across production subsidiaries, creating inconsistency in execution and compliance. - Regulatory Audit Challenges
Facilities faced difficulty maintaining readiness for GMP re-certification and FDA site inspections due to non-standardized SOPs and risk control mechanisms. - Limited EHS Oversight
Safety responsibilities were fragmented, with reactive rather than preventive controls at some production sites. - Insufficient Internal Review Cycles
Lack of structured internal audits and CAPA follow-ups weakened process traceability and risk prevention.
Site-Level Quality Framework Enhancement
A standardized multi-site audit framework and inspection preparation mechanism were developed and deployed across Sihuan’s production units.
- Unified Annual Quality Audit Plan
Group quality center coordinated audit schedules, reviewer training, and risk-prioritized coverage of key production sites. - Inspection Simulation & Mock Audits
FDA-style audit drills were conducted with full documentation trace-back and site walkthroughs to reinforce regulatory alignment. - CAPA Response System
Root cause tools such as 5Whys and Fishbone Analysis were introduced to standardize investigation and corrective measures.
EHS Governance & Safety System Upgrade
The EHS department initiated a series of proactive safety management strategies.
- Risk Matrix Mapping
Conducted risk classification and scenario-based simulations for top incidents, defining red-zone operations and controls. - Safety Audit Mechanism
Launched group-level quarterly safety inspection rounds, paired with site-level escalation and resolution tracking. - Employee Engagement Program
Rolled out EHS awareness training and reward system to build grassroots involvement in safety improvements.
Project Benefits
- GMP Audit Readiness
Passed domestic GMP re-certification audits in all subsidiaries within 6 months post rollout. - FDA Inspection Capability
Achieved consistent compliance scorecards during U.S. FDA site visits in two core production locations. - Safety Risk Reduction
Identified and mitigated 18 major safety risks across 5 plants, reducing potential downtime losses.