T/SHPPA 020-2023 Active Group standards

T/SHPPA 020-2023 Collection of production-grade genetically modified bacteria (membrane filtration method) technical specifications

Publish Date: 2023-05-28 Implement Date: 2023-06-12 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/SHPPA 020-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medicine, health, and labor protection

ICS Name: Quality management and quality assurance

Publish Date: 2023-05-28

Implement Date: 2023-06-12

Pages: 12 pages

Scope

Scope: This document is applicable to the production and quality management of genetically engineered bacteria collected by membrane filtration method for industrial use. For Phase III clinical trials and subsequent commercialization of live genetically engineered bacteria drugs, as well as the collection of fermentation bacteria in natural bacterial production, this document can be referenced. Main technical content: This technical specification stipulates the basic requirements and technical requirements for the collection of genetically engineered bacteria by membrane filtration method for industrial use. The basic requirements include regulations on institutions and personnel, plant and facilities, production management, material control, and change management; the technical requirements set forth requirements for materials, control, and cleaning.

Development Information

Pages: 12 pages

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