GB/T 12715-1991
Abolished
GB/T 46526-2025
Active
National standards
GB/T 46526-2025 Biotechnology—Analytical methods—Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
GB/T 46526-2025 Biotechnology—Analytical methods—Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
Price:
$ 81.00
Basic Information
Standard Code:
GB/T 46526-2025
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Basic standards and general methods
ICS Name:
Biology, botany, and zoology
Publish Date:
2025-10-31
Implement Date:
2026-05-01
Pages:
44 pages
Scope
This document provides guidance, a framework system, and a risk-based approach for the selection and validation of rapid microbial detection methods in the biomanufacturing process.
This document provides a flexible risk-based framework for detecting microbial contamination in the biomanufacturing process.
This document specifies general requirements and risks related to the production of cell therapy products, while also being flexible enough to adapt to the differences in specific production processes of each unique cell therapy product.
This document applies to sterility testing in the production of cell therapy products, as well as the production of other cell-derived therapeutic products.
This document focuses on rapid microbial testing methods (RMTM) used in process and final product testing.
This document does not apply to virus detection in the production of cell therapy products.
Development Information
Adopt standards
ISO 24190:2023