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

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 — 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document management system should function in such a way as to prevent the inadvertent use of documents that have been superseded. [...]