GB/T 46526-2025 Active
GB/T 46526-2025 Biotechnology—Analytical methods—Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
Abstract
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.
General Product Information
| Document Type | National standards |
|---|---|
| Standard Status | Active |
| Standard Code | GB/T 46526-2025 |
| CCS | Basic standards and general methods |
| ICS | Biology, botany, and zoology |
| Implement Date | 2026-05-01 |