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Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - validation: Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
|has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
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|module=4
|RefDocPart=Glossary - validation
|unit=4.2.3
|RefLanguage=EN
|scope=HM
|RefTagsEN=
|doc_part=Glossary - validation
|RefTagsOriginal=
|language=EN
|RefTagsFR=
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00127-Com-meC ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek
|tags_display=[[Glossary:TAG-00127-Com-meC|Systems validation]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]]
|comment=Definition of validation (GCP/ICH)
|content=validation
Action of proving, in accordance with the principles of Good Clinical Practice, that any procedure, process, equipment (including the software or hardware used), material, activity or system actually leads to the expected results.
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== Document Information ==
{{:Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995}}
== Reference Details ==
{| class="wikitable" style="width:100%;"
|-
! scope="row" style="width:200px;" | Scope
| HM
|-
! scope="row" style="width:200px;" | Document part
| Glossary - validation
|-
! scope="row" style="width:200px;" | Language
| EN
|-
! scope="row" style="width:200px;" | Original entry by
| Florian Adragna
|-
! scope="row" style="width:200px;" | Contributors
|
|-
! scope="row" style="width:200px;" | Tags (EN)
|
|-
! scope="row" style="width:200px;" | Tags (original language)
|
|-
! scope="row" style="width:200px;" | Tags (FR)
|
|-
! scope="row" | Comment
| Definition of validation (GCP/ICH)
|}
== Text ==
validation
Action of proving, in accordance with the principles of Good Clinical Practice, that any procedure, process, equipment (including the software or hardware used), material, activity or system actually leads to the expected results.

Latest revision as of 13:50, 16 July 2026



Document information
Reference WHO WHO - Guidelines for GCP for trials on

pharmaceutical products* 1995

Validity area WHO
Scope(s) HM
Document name WHO - Guidelines for GCP for trials on

pharmaceutical products*

Version / Revision 1995
Status Current
Document type International guideline
Language(s) EN
Description World Health Organization

WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products*

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 4 — Unit 4.2.3
Scope HM
Document part Glossary - validation
Language EN
Original entry by Florian Adragna
Contributors
Tags Systems validation, Definition, Good clinical practice

Content

validation Action of proving, in accordance with the principles of Good Clinical Practice, that any procedure, process, equipment (including the software or hardware used), material, activity or system actually leads to the expected results.

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