Ссылочный номер
ISO/TS 20399-1:2018
Технические спецификации
ISO/TS 20399-1:2018
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
Версия 1
2018-11
В время отменен
ISO/TS 20399-1:2018
67897
Отозвано (Версия 1, 2018)

Тезис

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.

Общая информация

  •  : Отозвано
     : 2018-11
    : Отмена международного стандарта [95.99]
  •  : 1
  • ISO/TC 276
    07.080 
  • RSS обновления

Жизненный цикл

Появились вопросы?

Ознакомьтесь с FAQ