T/SDSBME 001-2024 Active Group standards

T/SDSBME 001-2024 Guidelines for Quality Management System of Drug Development for Drug Research Institutions in Shandong Province

Publish Date: 2024-09-13 Implement Date: 2024-09-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SDSBME 001-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2024-09-13

Implement Date: 2024-09-20

Scope

Scope: This guideline is applicable to the establishment and operation of quality management systems for drug development activities aimed at the registration of chemical drugs and traditional Chinese medicines. The development activities of biological products can be implemented with reference to this guideline. Main technical content: To guide and standardize the quality management of drug development institutions and ensure the compliance of drug development activities, this guideline is formulated in accordance with laws and regulations such as the Pharmaceutical Administration Law of the People's Republic of China, the Drug Registration Management Regulations, and the ICH Q10 Pharmaceutical Quality System, as well as relevant guidance principles. This guideline aims to provide the concept and model of quality management systems for drug development, so that various drug development institutions or departments can refer to this guideline, combine their own characteristics, establish and optimize quality management systems for drug development, and improve the level of quality management.