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GB/T 46526-2025: Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
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Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
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Basic data | Standard ID | GB/T 46526-2025 (GB/T46526-2025) | | Description (Translated English) | Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | B04 | | Classification of International Standard | 07.080 | | Word Count Estimation | 42,42 | | Date of Issue | 2025-10-31 | | Date of Implementation | 2026-05-01 | | Issuing agency(ies) | State Administration for Market Regulation and Standardization Administration of China | GB/T 46526-2025: Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
National Standards of the People's Republic of China
ICS 07.080CCS B 04
Biotechnology analysis methods in biomanufacturing processes
Risk-based rapid detection methods for microorganisms
Select and confirm
Biotechnology-Analytical methods-Risk⁃based approach for method
selection and validation for rapid microbial detection in bioprocesses
(ISO 24190.2023, IDT)
Released on October 31, 2025
Implemented on 2026-05-01
State Administration for Market Regulation
The State Administration for Standardization issued a statement.
Table of contents
Preface III
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4.General considerations 5.
5.Microbial contamination risk management 6.
5.1 Risk Management in the Production Process 6
5.2 Risk Management of Microbial Testing 7
6.Choose a suitable testing method. 7.
6.1 General Rules 7
6.2 Selection of Measurement 7
6.3 Reagent Kit or System Selection 8
6.4 Precautions for various test types 8
6.5 User Requirements Specification 9
7 Confirm 10
7.1 General Concepts 10
7.2 Selection of Microorganisms 11
7.3 Quality Design for Method Validation 11
7.4 Re-confirmation of the method 12
7.5 System Confirmation 12
7.6 Use of reference materials/standard samples 12 in validation
7.7 Acceptance Criteria for Target Verification Parameters 12
7.8 Precision 13
7.9 Detection limit 13
7.10 Accuracy 13
7.11 Robustness 13
7.12 Durability 14
8.Use and Application of Rapid Microbial Detection 14
8.1 Quantity and Type of Samples 14
8.2 Test Environment 14
8.3 Sensitivity 14
8.4 Analytical Specificity (Microbial Detection) 14
8.5 Comparable test data 15
9.Investigation of positive sterile results 15
10 training sessions 15
11 Document 16
12 Test Report 16
Appendix A (Informative) A Paradigm Framework for Identifying Microbial Contamination 17
Appendix B (Informative) Donor Selection in Risk Analysis of Input Materials Related to Cell Therapy Products 18
Appendix C (Informative) Risk Analysis of Input Materials Related to Cell Therapy Products. Cell Transformation and Expansion 19
Appendix D (Informative) Risk Analysis of Input Materials Related to Cell Therapy Products. Packaging, Storage, and Management 20
Appendix E (Informative) Risk Classification of Cell Therapy Product Manufacturing Monitoring Practices 21
Appendix F (Informative) Validation of Rapid Microbial Detection Methods 22
F.1 Overview 22
F.2 Detection limit 22
F.3 Robustness 23
Appendix G (Informative) 24 Microorganisms Used to Confirm Rapid Microbial Detection Methods
Appendix H (Informative) Rapid Detection Methods for Microorganisms 28
H.1 Sequence-based methods 28
H.2 Solid-phase cell analyzer 28
H.3 Tilted Nanoarray 28
H.4 Spectral Analysis and Partial Least Squares Method 28
H.5 Bioluminescence-based testing 28
H.6 Mass Spectrometry 28
H.7 Flow cytometry 29
H.8 Liquid Chromatography-Mass Spectrometry 29
H.9 Binding affinity determination 29
Appendix I (Informative) Environmental Monitoring 32
References...33
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).
This document was drafted by. Institute of Biology, China Academy of Testing Technology; Chengdu Zhongke Aoge Biotechnology Co., Ltd.; and Chengdu Qipu Biotechnology Co., Ltd.
Biotechnology Co., Ltd., Beijing Academy of Science and Technology Analysis and Testing Institute (Beijing Physical and Chemical Analysis and Testing Center), Lanzhou Baiyuan Gene
Technology Co., Ltd., Mindray Bio-Medical Electronics Co., Ltd., Huayu Biotechnology (Tianjin) Co., Ltd., Sichuan New Life Stem Cell Technology Co., Ltd.
Limited Company, Shenzhen Yirui Biotechnology Co., Ltd., Sichuan University, Guangzhou Institute of Quality Supervision and Inspection, Chengdu Shilian Kangjian Biotechnology
Technology Co., Ltd., Sichuan Provincial Cell Bank Co., Ltd., Sichuan Tianfu Cell Quality Testing and Evaluation Center Co., Ltd., Changzhou Pharmaceutical Research Institute
Limited Liability Company, Guangzhou Shengan Medical Laboratory Co., Ltd., Hunan Guangxiu High-tech Life Technology Co., Ltd., Bailun Biotechnology (Jiangsu) Co., Ltd.
The company is Sichuan Zhenxing Testing Technology Co., Ltd.
The main drafters of this document are. Zhou Lihua, Pan Dengke, Gong Manlin, Xing Xiangyang, Wang Bingzhi, Yang Hengyu, Ye Deping, Luo Xujin, Ran Dan, and Song Lei.
Mu Chunlin, Tian Weidong, Long Tengxiang, He Guoshan, Du Meihong, Che Tuanjie, Yang Chao, Wu Kangli, Fu Hui, Tang Yingfeng, Wang Xili, Dai Shishi, Zhang Jingyi
Ju Donghua, Wen Yan, Li Qingsong, Geng Wenxin, Li Yan, Cheng Lamei, Wang Zhi, Zhu Lianming, Zhang Li.
Biotechnology analysis methods in biomanufacturing processes
Risk-based rapid detection methods for microorganisms
Select and confirm
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.
3.1
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).
3.2
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]
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