QUALITY STATEMENT

G Biological Products hereby declares that all activities related to the breeding of venomous animals, venom extraction, processing, storage, and supply are conducted within a structured quality framework aligned with Good Manufacturing Practice (GMP) principles, applicable regulatory expectations, and internationally accepted standards for biological material handling.

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Although venom production is not classified as the manufacture of finished medicinal products, G Biological Products has established a GMP-adjacent Quality Management System (QMS) designed to ensure consistency, traceability, safety, and scientific integrity of all supplied venom materials.

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All operational processes are governed by controlled Standard Operating Procedures (SOPs), including but not limited to animal management, venom extraction, processing, quality control, storage, labeling, and distribution. Personnel involved in venom-related activities are appropriately trained, qualified, and periodically reassessed for competency in biosafety, animal welfare, and quality procedures.

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Venom is sourced exclusively from captive-bred animals maintained under documented welfare protocols. Non-lethal extraction methods are employed, and extraction schedules are defined to respect animal recovery and venom regeneration cycles. Each venom lot is uniquely identified and fully traceable from source animal through final release.

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Quality control activities are conducted in accordance with predefined internal specifications and may include sterility screening, biochemical characterization, compositional profiling, and stability evaluation, as applicable to the intended use of the material. All results are documented, reviewed, and retained under controlled record management procedures.

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Storage, packaging, and transportation conditions are defined, monitored, and documented to preserve venom integrity and biological activity. Distribution is limited to qualified customers operating under appropriate regulatory, ethical, and biosafety approvals.

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G Biological Products maintains documented procedures for deviation management, change control, corrective and preventive actions (CAPA), and continuous improvement. The quality system is periodically reviewed to ensure ongoing alignment with evolving regulatory expectations and advances in toxinology and life sciences.

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This Quality Statement confirms G Biological Products’ commitment to providing ethically sourced, scientifically characterized, and quality-controlled venom materials suitable for regulated research, antivenom manufacturing, and pharmaceutical development pathways.