ISO DIS 21899

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

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Organization: ISO
Publication Date: 7 March 2019
Status: active
Page Count: 25
ICS Code (Biology. Botany. Zoology): 07.080
scope:

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

Document History

ISO DIS 21899
March 7, 2019
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 necessary for a biobank to be able to demonstrate that it operates its production of biological materials with validated and/or...

References

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