Vendor Qualification and Supplier Assessment Summary

Vendor Qualification and Supplier Assessment Summary

Supplier: G Biological Products

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1. Supplier Overview
G Biological Products is a specialized biotechnology supplier engaged in the ethical breeding of venomous animals and the extraction, processing, and supply of snake and scorpion venom for research, antivenom production, diagnostic development, and pharmaceutical R&D.

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2. Quality System and Governance
The supplier operates under a documented GMP-adjacent Quality Management System. Core quality elements include controlled SOPs, personnel training records, batch documentation, deviation handling, and change control procedures. Quality oversight is maintained through internal review mechanisms.

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3. Regulatory and Ethical Compliance

• Captive breeding only; no reliance on wild-caught specimens

• Non-lethal venom extraction techniques

• Compliance with internationally accepted animal welfare principles

• Alignment with biosafety and biological material handling regulations

• No supply of finished medicinal products unless explicitly contracted

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4. Facility and Biosafety Controls
Operations are conducted in access-controlled laboratory environments designed to minimize contamination and ensure personnel safety. Environmental conditions, sanitation, and material segregation are defined and documented.

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5. Traceability and Documentation
Full traceability is maintained from source animal to final venom lot. Each batch is accompanied by documentation including extraction date, processing method, storage conditions, and quality status.

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6. Quality Control and Testing
Quality control measures are applied based on intended use and may include sterility screening, biochemical profiling, enzymatic activity assessment, and stability monitoring. Analytical data are reviewed prior to material release.

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7. Storage, Packaging, and Distribution
Venom materials are stored and transported under validated conditions appropriate to their physical form. Packaging and labeling ensure product integrity, identification, and handling safety throughout the supply chain.

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8. Risk Management and Continuous Improvement
Operational risks are assessed through documented procedures. Deviations and changes are evaluated for impact, and corrective actions are implemented as required. Continuous improvement is supported through periodic system reviews.

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9. Supplier Assessment Conclusion
Based on the documented quality framework, ethical standards, and operational controls, G Biological Products is considered a qualified supplier of venom-derived biological materials suitable for regulated research and pharmaceutical development activities, subject to customer-specific qualification and audit requirements.