T/SHPPA 020-2023 Active
T/SHPPA 020-2023 Collection of production-grade genetically modified bacteria (membrane filtration method) technical specifications
Abstract
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.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/SHPPA 020-2023 |
| CCS | Medicine, health, and labor protection |
| ICS | Quality management and quality assurance |
| Implement Date | 2023-06-12 |