Elemental impurities work begins ahead of ICH Q3D
Ergopharm has begun risk-assessing its products for elemental impurities, working from the draft of what would become ICH Q3D rather than waiting for the final text.
The shift the guideline introduced was from a broad, non-specific heavy-metals limit test to a risk-based assessment of the specific elements that could plausibly be present, from the drug substance, the excipients, the water, the equipment or the container closure. That is a different exercise: it asks where a metal could come from, not merely whether a colour changes in a tube.
“The question stopped being 'does it pass the test' and became 'where could it possibly come from'.”
Assessments considered each potential source in turn and were supported by testing where the risk assessment could not exclude an element on documented grounds. Inductively coupled plasma mass spectrometry was introduced to the laboratory for this purpose.
The guideline was later revised as ICH Q3D(R2); the site's assessments reference the current revision and are revisited when a source of material changes.
Key facts
- Approach
- Source-based risk assessment, not a general limit test
- Sources considered
- Drug substance, excipients, water, equipment, container
- Technique
- ICP-MS introduced for confirmatory testing
- Current revision
- ICH Q3D(R2)
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.