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| Guideline | Date into Effect | Organization | Status | Link |
|---|---|---|---|---|
| Annex 11 - Computerised Systems | - | |||
|
Annex 15 - Qualification and Validation
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. |
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