EMA: Concept Paper on the Revision of Annex 15
EMA and PIC/S have published a concept paper outlining a targeted revision of Annex 15 (Qualification and Validation).
Background of the revision
The revision is largely driven by the nitrosamine (sartan)
case. The “lessons learnt” report identified shortcomings in process and
product knowledge, validation practices, change control and contamination
control among active substance manufacturers.
A key recommendation was to make Annex 15 mandatory for active substance manufacturers.
In addition, Annex 15 will be aligned with ICH Q9 (R1) on Quality Risk Management.
Key elements of the proposed revision
Qualification and Validation
- Extension of scope to chemical and biological active substance manufacturers (mandatory application)
- For
API manufacturers strengthening of:
- Validation Master File
- Qualification & Validation policy
- Investigation of results not meeting predefined acceptance criteria
- Oversight of third-party validation activities
- Supplier qualification
- Process validation activities to process recovery of materials and solvents
GDP Principles
The integration of Good Distribution Practices (GDP) for
active substances is foreseen. Expanded requirements for transport verification
are planned.
ICH Q9 (R1)
Annex 15 is intended to be specifically aligned with the updated version of ICH Q9 (R1):
- Stronger emphasis on Quality Risk Management (QRM) in design and validation of monitoring systems
- Integration of risk reviews to support qualification and validation
- Application of QRM also in the context of traditional processes
The public consultation will end on 9 April 2026. The revised Annex 15 is expected to be published by December 2026
Source:
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