Active substance sourcing controls aligned to ICH Q7
Ergopharm has aligned its active-substance sourcing controls to ICH Q7, the GMP guideline for active pharmaceutical ingredients, so that supplier assessment addresses how the material was made rather than only how it tests.
A certificate of analysis describes a sample. It says nothing about whether the manufacturing process was controlled, whether the impurity profile is consistent between campaigns, or whether the material was made where the paperwork says it was. Those questions are answered by assessing the manufacturer, not the sample.
“A certificate of analysis describes one sample. It does not describe a process.”
Assessment covers the process description, the impurity and residual solvent profile, the controls at each step, the change notification commitments, and the manufacturing site actually used. Incoming material is tested by Ergopharm for identity on every container and against the full specification per the site's own sampling plan, rather than accepted on the supplier's certificate alone.
Where a supplier changes anything material to the process, the change notification commitment in the quality agreement is what makes it visible in time to assess.
Key facts
- Reference
- ICH Q7 — GMP for active pharmaceutical ingredients
- Assessed
- Process, impurity profile, controls, actual site of manufacture
- Incoming
- Identity on every container; full testing per sampling plan
- Agreement
- Change notification commitments in writing
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.