Quality
As a CDMO company, quality stands as the foremost priority.
Employing robust quality systems and demonstrating proven regulatory track records at a GMP facility,
LOTTE BIOLOGICS is committed to supplying products of the highest quality to customers.
Quality management system
- PROCESS AND PRODUCTION CONTROL
- Manufacturing Batch Records
- In-Process Controls
- Supplier Qualification
- CHANGE MANAGEMENT
- Change Control
- Change Risk Assessment
- CORRECTIVE AND PREVENTIVE ACTION
- Deviation/Non-conformance
- Corrective and Preventive Action
- CAPA effectiveness check
- MANAGEMENT RESPONSIBILITY
- Management Review
- Inspection Readiness
- Internal Audit
- RESOURCES
- Personnel Competency
- Infrastructure
- Work Environment
- PRODUCT SURVEILLANCE
- Product Complaint
- Investigation
- Risk Monitoring
- DESIGN CONTROL
- Risk Management
Quality and regulatory compliance is
our priority at LOTTE BIOLOGICS.
LOTTE BIOLOGICS is committed to providing the highest quality products to our customers.