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Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report -: Difference between revisions

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|tags=TAG-00132-Goo-rst ++ TAG-00343-Doc-ten ++ TAG-00035-Man-odu
== Document Information ==
|tags_display=[[Glossary:TAG-00132-Goo-rst|Good manufacturing practice]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00035-Man-odu|Manufacturing]]
{{:Document:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report}}
|comment=GMP documentation principles
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|content=Annex 3: WHO good manufacturing practices: main principles for pharmaceutical products
== Reference Details ==
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== Text ==
Annex 3: WHO good manufacturing practices: main principles for pharmaceutical products
[...]
[...]
15. Documentation
15. Documentation
Line 60: Line 27:
When a document has been revised, the document management system should function in such a way as to prevent the inadvertent use of documents that have been superseded.
When a document has been revised, the document management system should function in such a way as to prevent the inadvertent use of documents that have been superseded.
[...]
[...]
}}

Latest revision as of 13:50, 16 July 2026



Document information
Reference WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth

report

Validity area WHO
Scope(s) G
Document name WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS
Version / Revision Forty-fifth

report

Status N.A.
Document type Other
Language(s) EN
Description WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS

Forty-fifth repor

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


Reference Details
Module Module 4 β€” Unit 4.2.2
Scope G
Document part -
Language EN
Original entry by Florian Adragna
Contributors
Tags Good manufacturing practice, Documentation, Manufacturing

Content

Annex 3: WHO good manufacturing practices: main principles for pharmaceutical products [...] 15. Documentation [...] 15.6 Where documents require the entry of data, these entries should be clear, legible and indelible. Sufficient space should be provided for such entries.

15.7 Any alteration made to a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded. […] Annex 4: WHO guidelines on good manufacturing practices for blood establishments […] 5.2 Document control [...] 5.2.1 Document management […] When a document has been revised, the document management system should function in such a way as to prevent the inadvertent use of documents that have been superseded. [...]

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