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GMP + GDP

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.

Type

GMP + GDP

Organisaties:

EMA

Versietijdlijn

Chronologische releasegeschiedenis

EMA/INS/GMP/20217/2026

Versiemijlpaal

Concept

Publicatiedatum

2026-01-19

guidelines.detail.timeline.expected_date

2026-12-01

Belangrijkste updates: Annex 15 will become mandatory for active substances manufacturers, an enhanced focus on robust process development and clarification on the concurrent validation approach. More emphasis on QRM in design and qualification activities.
Open versie Download

Ares(2015)1380025 - 30/03/2015

Versiemijlpaal

Publicatiedatum

2015-03-30

Ingangsdatum

2015-10-01

Open versie Download