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PD ISO/TS 20399-1:2018

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biotechnology. Ancillary materials present during the production of cellular therapeutic products General requirements

Available format(s)

Hardcopy , PDF

Superseded date

16-01-2023

Language(s)

English

Published date

06-02-2019

The British Standards InstitutionThis document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.

This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.

This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.

This document does not cover the selection, assessment or control of starting materials and excipients.

NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

Committee
BTI/1
DocumentType
Standard
ISBN
9780580942471
Pages
20
ProductNote
THIS STANDARD ALSO REFERS TO PAS 84:2012, , ICH Q3D, ICH Q7, ICH Q3B
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
ISO/TS 20399-1:2018 Identical

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