ICS 03.1 20.10 CCS C 00 GROUP STANDARD T/SHPPA 010(E)－2025 Replace T/SHPPA 010 -2021 Technical requirements for digital quality assurance in pharmaceutical production 药品生产数字化质量保证技术要求 (English Tran slation) Issue date ：2025-06-16 Implementation date：2025-06-28 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 010－2025 I Contents Foreword ................................ ................................ ............. II Introduction ................................ ................................ ......... Ⅳ 1 Scope ................................ ................................ .............. 1 2 Normative references ................................ ............................... 1 3 Terms and definitions ................................ .............................. 1 4 Technical requirements ................................ ............................. 3 4.1 Basic requirements for DQA construction ................................ ........ 3 4.2 Application functions of DQA ................................ ................... 3 4.3 Acquisition of pharmaceutical production data ................................ .. 4 4.4 DQA compliance management and early warning ................................ .... 6 4.5 Implementation of DQA ................................ .......................... 8 4.6 Risk management ................................ ............................... 10 4.7 Data format and interface ................................ ..................... 10 Bibliography ................................ ................................ ......... 11 全国团体标准信息平台 T/SHPPA 010－2025 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 . This document replaces the T/SHPPA 010 -2021 Technical requirements for digital quality assurance in pharmaceutical production in whole .In addition to a number of editorial changes,the following technical deviations have been made with respect to the T/SHPPA 010 -2021: a）Increased provisions for access to critical traceability data (see 4.3.1.7) ； b）Increased provisions for integration of artificial intelligence technology (see 4.5.7) ； c）Increased provisions fo r storage and backup (see 4.5. 8). Attention is drawn to the po ssibility 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 Drug Evaluation and Verification Center and Shanghai Pharmaceutical Profession Association. The main drafters of this do cument: Cao Meng ， Ge Yuanyuan, ，Han Bin， Wang Chong ， Zhang Jingchen ， Chen Guiliang, ，Ge Yuqing ，Zhang Jinwei ，Yang Qing ，Yi Zhengyu ，Wu Yaowei and Zhu Beifen. The initial implementing entities of this document are Shanghai Fosu n Kairos Biotechnology Co.，Ltd.，Merck & Co. (Jiangsu) Co. ，Ltd.，Shanghai Danrui Biomedical Technology Co. ，Ltd.， Sanofi (Hangzhou) Pharmaceutical Co., Ltd. ，Shanghai Sibiman Biotechnology Co., Ltd. ，Shenzhen Sanofi Pasteur Biological Co. ，Ltd.，Shanghai institute of Microsystem and information Technology Chinese Academy of Sciences ，Shanghai Knowhub Technologie Co. ，Ltd.，Shanghai Mianyi 全国团体标准信息平台 T/SHPPA 010－2025 III Biopharmaceutical Co. ，Ltd.，OBiO Te