T/GDFDTAEC 09-2024 Guidelines for Substantive Equivalence Verification of Process Changes for the Production of Health Food Products
T/GDFDTAEC 09-2024 Guidelines for Substantive Equivalence Verification of Process Changes for the Production of Health Food Products
Basic Information
Scope
Main technical content: This document describes the management process for the verification of substantial equivalence of changes in the production process of health food products, including the classification of changes in the production process, the technical requirements and judgment criteria for the verification of substantial equivalence of changes in the production process, the process of verification of substantial equivalence of changes in the production process, risk assessment of changes in the production process, the formulation of verification plans, the implementation of verification, and the requirements for verification reports. This document is applicable to verifying whether the products before and after changes in the production process of registered or filed health food products maintain consistency in terms of safety, health functions, and quality controllability. It is not applicable to changes that are not allowed in the registration and filing of health food products.