The EMA and PIC/S have published a new Concept Paper on the revision of EU GMP Annex 15 – Qualification & Validation, signalling a major shift in how the industry is expected to approach process validation and equipment qualification in the coming years.
This update is more than a routine revision; it reflects the regulatory lessons learned from recent quality failures, including nitrosamine contamination, and the need for a more science‑driven, risk‑based, and lifecycle‑oriented validation framework.
Why this matters:
Annex 15 has long been a cornerstone of GMP expectations, but its scope and depth no longer fully reflect today’s manufacturing realities. The revision aims to modernize the guideline and strengthen the link between process understanding, risk management, and ongoing verification.
Key themes emerging from this concept paper:
- Expanded Applicability; For the first time, Annex 15 will explicitly apply to chemical and biological active substance manufacturers, moving from optional guidance to a formal expectation assessed during inspections.
- Stronger Integration with ICH Q9 (R1); The revision reinforces the updated principles of Quality Risk Management, ensuring that risk assessments meaningfully drive validation strategy, sampling plans, acceptance criteria, and lifecycle monitoring.
- Lifecycle Validation Emphasis; Expect a clearer focus on: 1) Process knowledge and scientific justification 2) Enhanced contamination‑control strategies 3) More robust investigation practices 4) Continuous verification and trending
- Alignment with “Lessons Learned” Reports; The concept paper directly references insights from recent contamination and quality‑defect investigations, highlighting the need for improved control strategies and better understanding of process vulnerabilities.
Public Consultation Timeline:
The consultation runs from 9 February 2026 to 9 April 2026, giving industry stakeholders a critical window to provide feedback before the guideline is finalized.
What this means for industry:
The direction is clear: validation must evolve. Companies will need to strengthen their scientific rationale, risk‑based decision‑making, and lifecycle monitoring capabilities. This will impact QA, validation, manufacturing, and technical operations across the board.
The upcoming revision of Annex 15 is a pivotal moment—one that will shape validation expectations for the next decade.
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