DANSK DSF/ISO/FDIS 21899 PDF

This document specifies the validation and verification requirements necessary for a biobank to be able to demonstrate that it operates its production of biological materials with validated and/or verified methods that are fit-for-purpose. This document is intended for the use by biobank laboratories in the implementation, and validation or verification of their processing methods. It can also be used by biological material recipients, regulatory authorities and accreditation bodies. This document covers method validation and verification for the production of all biological materials. This document does not apply to processing methods of biological materials intended for food production or therapeutic use. Reference material production is not covered in this document. For the production requirements for reference materials, see ISO 17034.