T/CBPIA 0018-2026 Risk Assessment and Control Strategy for Polypeptide Drug Co-Manufacturing Operations

Scope

The outstanding technical features of this guideline are reflected in the following aspects: First, it enhances the rigor and professionalism of HBEL evaluation: For the potential special risks of polypeptide drugs (such as immunogenicity and the potential activity of degradation products), the guideline details the derivation method of HBEL based on pharmacological/toxicological data, emphasizes the in-depth requirements for the quality of key studies, the selection of uncertainty factors, and scientific demonstration, laying a solid foundation for establishing scientifically reasonable residual limits. Second, it improves the evidentiary strength of degradation studies in cleaning validation: Fully recognizing the potential degradation products of polypeptides under cleaning agents and process conditions, the guideline requires more targeted degradation pathway studies and incorporates the toxicological concerns of residuals and their degradation products into the cleaning validation strategy, ensuring that cleaning methods can effectively eliminate the residual risks of products and their potential degradation products. Third, it clarifies the logical clarity and operability of risk classification: Combining the multi-dimensional attributes of polypeptide products such as toxicity, pharmacological activity, solubility, and cleaning difficulty, the guideline constructs a hierarchical and logical risk classification and evaluation process, guiding enterprises to scientifically identify the "worst conditions" in co-production and formulate corresponding differentiated control strategies. Fourth, it pays attention to the detailed alignment with international technical guidelines and localized practices: The guideline is developed on the basis of the relevant quality risk management and cleaning validation guidelines of the National Medical Products Administration, and fully references and integrates the advanced principles of the International Conference on Harmo

Development Information

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