Quality & Compliance
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Commitment to Quality Excellence
At Floragen Biopharma, quality is not a department—it is a culture embedded in every stage of our bio-pharmaceutical operations. From research and development to manufacturing and distribution, we maintain uncompromising standards to ensure the safety, efficacy, and consistency of our products.
Our Quality Philosophy
We believe that patient safety and therapeutic effectiveness begin with strict quality control and regulatory compliance. Our integrated quality management system ensures that every product meets international pharmaceutical standards while exceeding stakeholder expectations.
Floragen Biopharma strictly complies with all applicable global regulatory standards, including:
Floragen Biopharma strictly complies with all applicable global regulatory standards, including:
Our robust Quality Management System (QMS) governs all processes and procedures to maintain consistency, traceability, and control.
Key QMS elements include:
- Document control & data integrity
- Internal audits & management reviews
- Change management & deviation control
- Corrective and Preventive Actions
Manufacturing Quality Control
- Raw material qualification
- In-process quality monitoring
- Final product testing & stability studies
- Batch record review & product release authorization
Validation & Risk Management
- Equipment & facility validation
- Process & cleaning validation
- Computer system validation (CSV)
- Risk assessment & mitigation strategies
Data Integrity & Documentation
- ALCOA+ data integrity principles
- Audit-ready documentation practices
- Audit-ready documentation practices
Training & Quality Culture
- Quality awareness initiatives
- Role-specific certification programs
- GMP & compliance training
Our principles include:
- Risk-based quality decision-making
- Full regulatory transparency
- Zero compromise on product quality
Quality & Compliance
At Floragen BioPharma, quality is integral to every step of our process—from botanical sourcing to final product formulation. Our commitment to excellence ensures that every product meets the highest standards of safety, purity, and efficacy.
cGMP Certified Facilities:
Our manufacturing processes comply with current Good Manufacturing Practice standards
Sustainable Sourcing:
Ethically harvested botanicals from certified suppliers with full traceability
Advanced Analytics:
Comprehensive testing including HPLC, GC-MS, and NMR for compound verification
Regulatory Expertise:
Full compliance with FDA, EMA, and international regulatory requirements
Stability Studies:
Rigorous testing to ensure product integrity throughout shelf life
Quality Control:
Multi-stage quality checks from raw materials to finished products
