T/CBPIA 0007-2024 Guidelines for Quality Management of Animal-derived Raw Materials for Artificial Cow Bezoar Production

Scope

Scope: This guideline stipulates the general requirements for the production process, quality management and control, and traceability management of animal-derived raw materials (hereinafter referred to as animal-derived raw materials) used in the production of artificial bile salts, including bovine bile powder, cholesterol, porcine deoxycholic acid, bile acid, and bilirubin. Artificial bile salts production enterprises can refer to this guideline for quality control of the process from the collection of starting materials to the production of animal-derived raw materials. However, this guideline does not apply to artificial bile salts and their preparations. If there are changes in the production process of animal-derived raw materials for artificial bile salts, they shall be implemented in accordance with current regulations and the requirements of the technical guidelines for changes, and shall not change the approved registration or registration process based on this guideline. Main technical content: This guideline is drafted in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work - Part 1: Structure and Drafting Rules for Standardization Documents". This guideline applies to the production management, quality assurance and quality control, and traceability management of animal-derived raw materials for artificial bile salts. For artificial bile salts preparations, holders of drug marketing authorizations or registrants of artificial bile salts can refer to this guideline for quality control of the process chain from the acquisition of starting materials to the production of artificial bile salts. It is worth noting that if there are changes in the production process of animal-derived raw materials for artificial bile salts, they shall be implemented in accordance with current regulations and the requirements of the technical guidelines for changes, and shall not change the approved registration or registration process based on

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