ISO 21973:2020 pdf download

ISO 21973:2020 pdf download.Biotechnology — General requirements for transportation of cells for therapeutic use
1 Scope
This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation. Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination. This document does not apply to transportation of cells within one facility. This document includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation. This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 cells for therapeutic use
product containing cells as the active substance
EXAMPLE Cell therapy medicinal product, tissue engineered product.
Note 1 to entry: For the purpose of this document, “cells” mean human cells and tissues of autologous as well as allogeneic.
Note 2 to entry: For the purpose of this document, this term includes cells collected as starting materials and cultured as intermediate materials.
Note 3 to entry: The expression “therapeutic use” includes clinical research, hospital exception and testing use.
3.2 chain of custody
responsibility for or control of materials as they move through each step of a process
Note 1 to entry: For the purpose of this document, “chain of custody” is the proven path starting from the transfer of the packaged cells from the sender (3.11) to the transportation service provider (3.13) and ends when the package is received at its destination.
3.4 document
information and the medium on which it is contained EXAMPLE Record, specification, procedure document, drawing, report, standard.
Note 1 to entry: The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or combination thereof.
Note 2 to entry: A set of documents, for example specifications and records, is frequently called “documentation”.
Note 3 to entry: Some requirements (e.g. the requirement to be readable) relate to all types of documents. However there can be different requirements for specifications (e.g. the requirement to be revision controlled) and for records (e.g. the requirement to be retrievable). [SOURCE: ISO 9000:2015, 3.8.5]