Date of Publication: 09-Feb-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency (EMA) has released a Concept Paper outlining plans to revise Annex 15 of the EU Good Manufacturing Practice (GMP) guidelines, which covers qualification and validation requirements for facilities, equipment, systems, and processes in pharmaceutical manufacturing.
Annex 15 is a core part of the GMP framework, ensuring that manufacturers demonstrate documented evidence of control and consistent performance throughout the product and process lifecycle, from installation and operation to performance qualification and ongoing process verification.
The planned revision aims to update the guideline to reflect modern manufacturing practices, risk-based approaches, and lifecycle principles, incorporating concepts from ICH Q8 (pharmaceutical development), Q9 (quality risk management), and Q10 (pharmaceutical quality systems). It also seeks to align with other updated GMP components including changes in technology, computerized systems, continuous process verification, and quality risk management while promoting clarity, consistency, and harmonisation with global expectations.
KEYWORDS: Manufacturing Quality, Qualification Validation, Lifecycle Validation
REFERENCE: https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf https://www.ema.europa.eu/en/news-events/whats-new