T/CBPIA 0006-2023 Active

Scope: This guideline stipulates the general requirements for the production process, quality management and control, and traceability management of crude human urine-derived proteins. The drug marketing authorization holder (hereinafter referred to as MAH) or the registrant of the API may refer to this guideline to implement quality control of the process chain from obtaining starting materials, producing process intermediates to manufacturing APIs for human urine-derived protein preparations and their raw materials. In this guideline, the term "product" refers to crude human urine-derived proteins and process intermediates, APIs, and finished preparations involved in the upstream and downstream process chains. However, this guideline does not apply to finished preparations and APIs of human urine-derived proteins. Main technical content: This guideline is drafted in accordance with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines - Part 1: Structure and Drafting Rules for Standardization Documents". This guideline applies to activities such as production management, quality assurance and control, and traceability management of crude human urine-derived proteins. MAHs or registrants of APIs may refer to this guideline to implement quality control of the process chain from obtaining starting materials, producing intermediates to manufacturing APIs for human urine-derived protein preparations and their raw materials. It is worth noting that if there are changes in the production process of crude human urine-derived proteins, they shall be implemented in accordance with current regulations and the requirements of the change technical guidelines, and shall not change the approved registration or registration process based on this guideline.