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GMP + GDP Draft

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.

Organizations:
EMA
Topics:
Qualification & Validation

Version Timeline

Chronological release history

EMA/INS/GMP/20217/2026

Version milestone

Draft

Publication Date

Jan 19, 2026

guidelines.detail.timeline.expected_date

Dec 1, 2026

Main 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.
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Ares(2015)1380025 - 30/03/2015

Version milestone

Publication Date

Mar 30, 2015

Effective Date

Oct 1, 2015

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