GB/T 46526-2025Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses (English PDF)

Foreword

This document conforms to GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting is scheduled.

This document is equivalent to ISO 24190:2023 "Analytical methods for biotechnology – Risk-based microbial analysis in biomanufacturing processes".

Selection and Validation of Rapid Detection Methods for Substances.

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed and is under the jurisdiction of the National Technical Committee on Standardization of Biochemical Testing (SAC/TC 387).

1 Scope

This document provides guidance, a framework, and risk-based considerations for the selection and validation of rapid microbial detection methods in biomanufacturing processes.

The method.

This document provides a flexible, risk-based framework for detecting microbial contamination in biomanufacturing processes.

This document outlines the general requirements and risks associated with the manufacture of cell therapy products, while also providing flexibility to adapt to each unique cell type.

Differences in the specific manufacturing processes of therapeutic products.

This document applies to sterility testing in the production of cell therapy products, and also to the production of other cell-derived therapeutic products.

This document focuses on rapid microbial testing methods (RMTM) for use in process and final product testing.

This document does not apply to virus testing in the production of cell therapy products.

2 Normative references

This document does not contain any normative references.

3 Terms and Definitions

The following terms and definitions apply to this document.

The URLs for the terminology databases maintained by ISO and IEC for standardization are as follows.

Acceptance criteria

Numerical limits, ranges, or other properties or variables that satisfy the predefined performance of the determination.

Note. Acceptance criteria are specified in User Requirements Specification (3.30).

accuracy

Measurement accuracy the consistency between the measured value and its true value.

Note 1.The concept of "measurement accuracy" is not a quantity, nor is a numerical value given. When the measurement error is small, the measurement is considered relatively accurate.

Note 2.The term "measurement accuracy" is not used to refer to the correctness of a measurement, and the term "measurement precision" is not used to refer to "measurement accuracy." However, it is related to both of these concepts.

Related to the concept.

Note 3."Measurement accuracy" is sometimes understood as the degree of consistency between the measured values of the measurand.

[Source. ISO 16140-1:2016, 2.2]