ISO 21973:2020 バイオテクノロジー—治療に使用するための細胞の輸送に関する一般的な要件 | ページ 6

3.1

cells for therapeutic use

product containing cells as the active substance

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.

3.3

client

entity requesting cell transportation by contract with transportation service provider (3.13)

3.4

document

information and the medium on which it is contained

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]

3.5

documented information

information required to be controlled and maintained by an organization and the medium on which it is contained

Note 1 to entry: Documented information can be in any format and media and from any source.

Note 3 to entry: This constitutes one of the common terms and core definitions for ISO management system standards given in Annex SL of the Consolidated ISO Supplement to the ISO/IEC Directives, Part 1.

[SOURCE:ISO 9000:2015, 3.8.6]

3.6

inspection

determination of conformity to specified requirements

[SOURCE:ISO 9000:2015, 3.11.7, modified — Notes to entry have been deleted.]

3.7

receiver

entity that gets cells for therapeutic use (3.1) from the transportation service provider (3.13)

3.8

record

document (3.4) stating results achieved or providing evidence of activities performed

Note 1 to entry: Records can be used, for example, to formalize traceability (3.12) and to provide evidence of verification (3.15) , preventive action and corrective action.

Note 2 to entry: Generally records need not be under revision control.

[SOURCE:ISO 9000:2015, 3.8.10]

3.9

risk assessment

overall process comprising a risk analysis and a risk evaluation

[SOURCE:ISO/IEC Guide 51:2014, 3.11]

3.10

risk control

process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels

[SOURCE:ISO/IEC Guide 63:2019, 3.12]

3.11

sender

entity that hands over cells for therapeutic use (3.1) to transportation service provider (3.13)

3.12

traceability

ability to trace the history, application or location of an object

Note 2 to entry: In the field of metrology, the definition in ISO/IEC Guide 99 is the accepted definition.

[SOURCE:ISO 9000:2015, 3.6.13]

3.13

transportation service provider

entity that provides international and domestic transportation service of cells for therapeutic use (3.1)

Note 1 to entry: Transportation service provider can outsource the whole or part of cell transportation to external service providers. In that case, some requirements described in this document [e.g. the requirement regarding documented information (3.5) ] can be met by the activities of external service providers. The activities of external service providers vary according to the agreement between the transportation service provider and external service provider, but its activities are managed by transportation service provider.

3.14

validation

confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination such as performing alternative calculations or reviewing documents (3.4) .

Note 2 to entry: The word “validated” is used to designate the corresponding status.

Note 3 to entry: The use conditions for validation can be real or simulated.

[SOURCE:ISO 9000:2015, 3.8.13]

3.15

verification

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection (3.6) or of other forms of determination such as performing alternative calculations or reviewing documents (3.4) .

Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.

Note 3 to entry: The word “verified” is used to designate the corresponding status.

[SOURCE:ISO 9000:2015, 3.8.12]