ICS 03.1 00.50 CCS C 01 GROUP STANDARD T/SHPPA 027（E）－2024 Technical requirements for digital twins in advanced pharmaceutical manufacturin g 药品先进制造数字孪生技术要求 (English Translation) Issue date ：2024-07-26 Implementation date：2024-09-02 Issued by Shanghai Pharmaceutical Profession Association 全国团体标准信息平台 全国团体标准信息平台 T/SHPPA 027－2024 I Contents Foreword ................................ ................................ ............. II Introduction ................................ ................................ ......... Ⅲ 1 Scope ................................ ................................ .............. 1 2 Normative references ................................ ............................... 1 3 Terms and definitions ................................ .............................. 1 4 Technical requirements ................................ ............................. 2 4.1 System architecture ................................ ............................ 2 4.2 System construction elements ................................ ................... 3 4.3 Functional requirements ................................ ........................ 3 4.4 Safety requirements ................................ ............................ 7 Bibliography ................................ ................................ ......... 11 全国团体标准信息平台 T/SHPPA 027－2024 II Foreword the Shanghai Pharmaceutical Profession Association is in charge of this English translation.In case of any doubt about the contents of English translation,the Chinese original shall be considered authoritative. This document is drafted in accordance with the rules given in the GB/T 1.1 -2020 Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.The issuing body of this document shall not be held responsible for identifying any or all such patent rights. This document was proposed by the Shanghai Center for Drug Evaluation . This document was prepared by the Shanghai Pharmaceutical Profession Association. This document was drafted by: Shanghai Center for Drug Evaluation and Inspection, Shanghai Biopharmaceutical Industry Promotion Center, Shanghai Biotechnology and Pharmaceutical Development Service Center, National Engineering Research Center for Advanced Pharmaceutical Manufacturing, Shanghai University of Engineering Science, Sanofi (China) Investment Co., Ltd. Shanghai Branch, Merck Chemical Technology (Shanghai) Co., Ltd., Fosun Kite BioPharma Co., Ltd., China Telecom Corporation Limited Shanghai Branch, Shanghai Jiujiu Information Technology Co., Ltd., Honeywell (China) Co., Ltd., and Shanghai Pharmaceutical Profession Association. The main drafters of this document: Cao Meng, Hu Lingyan, Wang Jian, Yuan Chunping, Chenzhuang Tianyi, Tian Feng, Shi Tong, Ruan Keping, Mei Rong, Wang Bin, Lu Guangwei, Dai Yan, Li Ling, Ma Xiang, Zhu Qilei, Liao Ping, Cao Hui, Chen Yifei, Dong Zhenglong, Chen Guiliang, Yi Zhengyu, Wu Yaowei, Zhu Beifen. The initial implementing entities of this document are Sanofi (China) Investment Co., Ltd. Shanghai Branch, Merck Chemical Technology (Shanghai) Co., Ltd., Fosun Kite BioPharma Co., Ltd., National Engineering Research Center for Advanced Pharmaceutical Manufacturing, China Telecom Corporation Limited Shanghai Branch, and Honeywell (China) Co., Ltd. 全国团体标准信息平台 T/SHPPA 027－2024 III Introduction The concept of the digital twin represents an innovative confluence of digital technology with the physical realm, whereby physical entities are digitally modeled to create corresponding virtual counterparts, thereby mapping the physical world into a digital framework. This document, inco