T_SHPPA 010-2025 药品生产数字化质量保证技术要求.docxVIP

ICS03.120.10CCSC00团体标准T/SHPPA010－2025代替T/SHPPA010-2021药品生产数字化质量保证技术要求Technicalrequirementsfordigitalqualityassuranceinpharmaceuticalmanufacturing2025-06-16发布2025-06-28实施上海医药行业协会发布

ICS03.120.10

CCSC00

团

体

标

准

T/SHPPA010－2025

代替T/SHPPA010-2021

药品生产数字化质量保证技术要求

Technical

requirementsfordigitalquality

assurance

in

pharmaceutical

manufacturing

2025-06-16发布

2025-06-28实施

上海医药行业协会

发布

T/SHPPA010－2025目次前言..................................................................................Ⅱ引言..................................................................................Ⅲ1范围................................................................................1

T/SHPPA010－2025

目

次

前言..................................................................................Ⅱ

引言..................................................................................Ⅲ

1范围................................................................................1

2规范性引用文件......................................................................1

3术语和定义..........................................................................1

4技术要求............................................................................2

4.1DQA构建基本要求.................................................................2

4.2DQA应用功能.....................................................................3

4.3药品生产数据获取................................................................3

4.4DQA合规管理和预警...............................................................4

4.5DQA实施.........................................................................5

4.6风险管理........................................................................6

4.7数据格式和接口..................................................................6

参考文献...............................................................................8

I

T/SHPPA010－2025前言本文件按照GB/T1.1－2020《标准化工作导则第