T/ZFDSA 01-2023 Quality Management Standards for the Production of Healthcare Products

Scope

Main technical content: This document was drafted by the Zhengzhou Food and Drug Supervision Association in accordance with the provisions of the "Standardization Law of the People's Republic of China", the "Regulations on the Management of Group Standards" issued by the National Standards Committee and the Ministry of Civil Affairs (No. [2019] 1 of the National Standards Committee), and GB/T 1.1-2020 "Guidelines for Standardization Work - Part 1: Structure and Drafting Rules for Standardization Documents". This document stipulates the requirements for institutions and personnel, plant and facilities, raw materials, production management, quality management, hygiene management, packaging and labeling, storage and transportation in the production of health products, and constitutes the basic requirements for the production and quality control of health products. This document is applicable to the evaluation and management of health product producers, operators, and service providers. It can be voluntarily adopted by all member units of the Zhengzhou Food and Drug Supervision Association and registered and archived by the association. Non-member units need to obtain written authorization before using it. The Zhengzhou Food and Drug Supervision Association is responsible for interpreting the document. Document name and number: T/ZFDSA 01-2023 "Quality Management Code for the Production of Health Products". Contact person of the association: Zhu Zhenzhen Contact phone number: 13323840431

Development Information

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