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BSI - BS ISO 20399

Biotechnology - Ancillary materials present during the production of cellular therapeutic products and gene therapy products

active, Most Current
Organization: BSI
Publication Date: 31 January 2023
Status: active
Page Count: 42
ICS Code (Biology. Botany. Zoology): 07.080

Document History

BS ISO 20399
January 31, 2023
Biotechnology - Ancillary materials present during the production of cellular therapeutic products and gene therapy products
A description is not available for this item.

References

This document references:
ASTM E3077 - Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
Published by ASTM on June 1, 2017
This guide is applicable to all elements of raw material electronic data (eData) transfer from a Supplier which provides a raw material to a Customer which receives the raw material. This guide is...
This document references:
ISO 13022 - Medical products containing viable human cells - Application of risk management and requirements for processing practices
Published by ISO on April 1, 2012
This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products,...
This document references:
ISO 35001 - Biorisk management for laboratories and other related organisations
Published by ISO on November 1, 2019
This document defines a process to identify, assess, control, and monitor the risks associated with hazardous biological materials. This document is applicable to any laboratory or other organization...
This document references:
8601-1 AMD 1 - Date and time — Representations for information interchange — Part 1: Basic rules AMENDMENT 1: Technical corrections
Published by ISO on October 1, 2022
A description is not available for this item.
This document references:
ISO GUIDE 73 - Risk management — Vocabulary
Published by ISO on January 1, 2009
This Guide provides the definitions of generic terms related to risk management. It aims to encourage a mutual and consistent understanding of, and a coherent approach to, the description of...
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