Reference:WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth report -: Difference between revisions
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Revision as of 17:29, 15 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 |
| Comment | GMP documentation principles |
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. Sufο¬cient 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. [β¦] Annex 4: WHO guidelines on good manufacturing practices for blood establishments [β¦] 5.2 Document control [...] 5.2.1 Document management [β¦] 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document management system should function in such a way as to prevent the inadvertent use of documents that have been superseded. [...]
