ISO 21899:2020
Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks
This document specifies the validation and verification requirements applicable to a biobank to be able to demonstrate that it operates its processing of biological materials with validated and/or verified methods that are fit for purpose.
This document is intended for use in the implementation and validation of processing methods for biological materials.
This document covers method validation and verification for the production of all biological materials. This document does not apply to biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use.
Reference material production is not covered in this document. For the production requirements for reference materials, see ISO 17034.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 General and resource requirements
6 Selection of processing methods
7 Processing method implementation
7.1 Targets for method implementation
7.2 Processing method implementation
8 Initial validation of a processing method
8.1 General
8.2 Validation plan
8.3 Assays for properties of interest
8.4 Validation execution
8.4.1 General
8.4.2 Validation site
8.4.3 In-house or outsourced testing
8.5 Targets for processing method validation
8.5.1 General
8.5.2 Fitness for purpose
8.5.3 Reproducibility
8.5.4 Robustness
8.5.5 Homogeneity
8.5.6 Stability
8.6 Review and approval of validation report
9 Further validation
10 Method verification
11 Ongoing monitoring of a processing method
11.1 General
11.2 Frequency of the monitoring
11.3 Planning
11.4 Procedure of the systematic monitoring
11.5 Procedure of the periodic monitoring
11.6 External quality assessments (EQA)/Interlaboratory exercises
12 Record keeping and archiving
Annex A (informative) Processing and testing methods
Annex B (informative) Examples of validation plans
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviated terms
5 General and resource requirements
6 Selection of processing methods
7 Processing method implementation
7.1 Targets for method implementation
7.2 Processing method implementation
8 Initial validation of a processing method
8.1 General
8.2 Validation plan
8.3 Assays for properties of interest
8.4 Validation execution
8.4.1 General
8.4.2 Validation site
8.4.3 In-house or outsourced testing
8.5 Targets for processing method validation
8.5.1 General
8.5.2 Fitness for purpose
8.5.3 Reproducibility
8.5.4 Robustness
8.5.5 Homogeneity
8.5.6 Stability
8.6 Review and approval of validation report
9 Further validation
10 Method verification
11 Ongoing monitoring of a processing method
11.1 General
11.2 Frequency of the monitoring
11.3 Planning
11.4 Procedure of the systematic monitoring
11.5 Procedure of the periodic monitoring
11.6 External quality assessments (EQA)/Interlaboratory exercises
12 Record keeping and archiving
Annex A (informative) Processing and testing methods
Annex B (informative) Examples of validation plans
Bibliography