ISO 21899:2020 PDF

Scope: 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.

ISO 21899:2020 Referenced Document

2020 ISO 21899:2020 Biotechnology — Biobanking — General requirements for the validation and verification of processing methods for biological material in biobanks