T/CBPIA 0013-2025 Guidelines for Quality Management of Medicinal Snake Venom Production

Scope

This guideline stipulates the general requirements for the production process, quality management and control, and traceability management of medicinal snake venom, including cobra, white-browed pit viper, pointed-snout pit viper, spearhead pit viper, and round-spotted viper. The production of related snake venom preparations and their starting materials shall comply with the Good Manufacturing Practice for Pharmaceutical Products. The quality control of the process chain, such as snake venom collection and intermediate product production, can refer to this guideline. The breeding of medicinal snakes shall refer to the Good Manufacturing Practice for Chinese Herbal Medicines. If there are changes in the production process of medicinal snake venom, they shall be implemented in accordance with current regulations and the requirements of the Technical Guidelines for Changes. The approved registration or production process shall not be changed based on this guideline. The specific methods and values described in the appendix of this guideline are guidance values for regulating the quality of medicinal snake venom production. Enterprises should determine reasonable acceptable standards based on factors such as the type of medicinal snakes, breeding methods, and quality control of snake venom preparations. This guideline applies to the production management, quality control and assurance, and traceability management of medicinal snake venom. The quality management of medicinal snake venom production shall follow Good Manufacturing Practice for Pharmaceuticals, ICH Q series, and the Chinese Pharmacopoeia, among other norms, standards, and guidelines. When implementing this guideline, if there are matters not covered by this guideline, international standards such as those of the WHO, FDA, and EMA may be referenced to ensure traceability of sources, controllability of processes, and reliability of quality. It is worth noting that if there are changes related to the prod

Development Information

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