This guide is drafted in accordance with the provisions of GB/T1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents". This guideline applies to activities such as production management, quality assurance and control, and traceability management of crude human urine-derived protein. Drug marketing authorization holders or API registrants can refer to these guidelines for quality control of the process chain of human urine-derived protein preparations and their APIs from starting material acquisition, intermediate production to API production. It is worth noting that any changes to the production process of crude human urine-derived protein should be carried out in accordance with current regulations and changes in technical guidelines. Approved registration or registration processes must not be changed based on these guidelines.
T/CBPIA 0006-2023 history
2023T/CBPIA 0006-2023 Quality Management Guidelines for Production of Crude Human Urinary Protein