What is ISO 21899 about?
ISO 21899 discusses validation and verification of processing methods for biological material in biobanks for biotechnology. ISO 21899 outlines the validation and verification requirements applicable to a biobank to be able to demonstrate. That is to operate its processing of biological materials with validated and/or verified methods that are fit for purpose.
ISO 21899 is intended for use in the implementation and validation of processing methods for biological materials.
ISO 21899 covers method validation and verification to produce all biological materials.
Note 1: ISO 21899 does not apply to biological material intended for food/feed production, laboratories undertaking food/feed analysis, and/or therapeutic use.
Note 2: Reference material production is not covered in ISO 21899. For the production requirements for reference materials, see ISO 17034.
Who is ISO 21899 for?
ISO 21899 on validation and verification of processing methods for biological material in biobanks is useful for:
- Biobanks
- Research facilities
- Quality control personnel
Why should you use ISO 21899?
Biobanks, producing viable and non-viable biological materials (human, animal, plant, microbial) for research purposes, within biotechnology, use processing methods. Many biobanks include processing laboratories where processing methods are performed, and biological materials are produced as an output. They are not always equipped to perform testing methods, which are required for annotation or qualification of the biological material output.
ISO 21899 guideline outlines general and resource requirements on the selection of processing methods, processing method implementation, initial validation of a processing method, further validation, method verification, ongoing monitoring of a processing method, and record-keeping and archiving for validation and verification of processing methods for biological material in biobanks. This helps in confirming the fitness, homogeneity, and stability of the biological material. ISO 21899 also helps in improving quality by verification of biological material.