GB/T 13339-1991
Abolished
T/SHQAP 003-2023
Active
Group standards
T/SHQAP 003-2023 Cell Therapy Product Production Space Enclosure System Application Guide
T/SHQAP 003-2023 Cell Therapy Product Production Space Enclosure System Application Guide
Price:
$ 20.00
Basic Information
Standard Code:
T/SHQAP 003-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Integrated services in the fields of medicine, health, and labor protection
ICS Name:
Quality management and quality assurance
Publish Date:
2024-01-08
Implement Date:
2024-02-07
Scope
Main technical content: This document provides terms and definitions for the airtight systems used in the production of cell therapy products (cell preparation isolators and associated culture systems), and offers suggestions on equipment configuration, equipment validation, aseptic process simulation, production process verification considerations, system risk control, and biosafety control, with the aim of reducing the potential risks of exogenous contamination, cross-contamination, mix-up errors, and biosafety issues in the production of cell therapy products, enhancing the aseptic protection level of the production process, and improving medication safety.
Development Information
Related Standards
GB/T 13340-1991
Abolished
GB/T 13340-1991 Methods for determination and calculation of quality grading rate of products
GB/T 13341-1991
Abolished
GB/T 13341-1991 Methods for determination and accounting of quality failure rate
GB/T 19004.3-1994
Abolished
GB/T 19004.3-1994 Quality management and quality system elements—Part 3:Guidelines for processed materials
GB/T 19004.2-1994
Abolished
GB/T 19004.2-1994 Quality management and quality system element—Part 2:Guidelines for services
GB/T 19000.4-1995
Abolished