Overview
ISO 21899:2020 - "Biotechnology - Biobanking - General requirements for the validation and verification of processing methods for biological material in biobanks" defines requirements for demonstrating that biobank processing methods are validated or verified and fit for purpose. It applies to processing methods used to produce biological materials (human, animal, plant, microbial) for research and excludes material intended for food/feed, therapeutic use, and reference material production (see ISO 17034).
Keywords: ISO 21899:2020, biobanking, validation, verification, processing methods, biological materials, fitness for purpose.
Key topics and requirements
- Scope and definitions: Clarifies terms such as aliquot, homogeneity, fitness for purpose, and processing vs testing methods.
- Resource and general requirements: Expectations for biobank laboratories, competence, and infrastructure to implement processing methods.
- Selection and implementation of methods: Guidance on choosing appropriate processing methods and defining targets for implementation.
- Initial validation: Requirements for a documented validation plan, selection of relevant assays for properties of interest (e.g., viability, purity, integrity), and execution of validation at appropriate sites (in-house or outsourced).
- Performance attributes: Emphasis on assessing fitness for purpose, reproducibility, robustness, homogeneity, and stability of the produced biological material.
- Qualification of equipment and processes: References to Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) concepts.
- Verification and monitoring: Ongoing method verification, systematic and periodic monitoring, and participation in external quality assessments (EQA) or interlaboratory exercises.
- Record keeping and archiving: Requirements for maintaining validation records, reports, and documentation for traceability.
Applications and users
ISO 21899:2020 is intended for:
- Biobank laboratories that process biological materials for research
- Quality managers and laboratory directors implementing or improving method validation systems
- External providers and contract laboratories involved in processing, testing, or storage
- Researchers and institutions who require confidence that biobank outputs are fit for intended downstream uses
Practical applications include validating DNA/RNA/protein extractions, cell culture processing workflows, aliquoting procedures, and stability/homogeneity assessments for distributed samples.
Related standards
- ISO 20387 - General requirements for biobanking (referenced for terms and broader quality systems)
- ISO 17034 - Requirements for production of reference materials (not covered by ISO 21899)
Using ISO 21899:2020 helps biobanks demonstrate credible, documented validation and ongoing verification of processing methods-improving reproducibility, traceability, and confidence in biological materials supplied for research.