Compendial methods verified for the site's own conditions
Ergopharm has completed verification of the compendial methods it uses for routine release, confirming that each performs as intended in its own laboratory, with its own instruments, analysts and samples.
A pharmacopoeial method is validated by the pharmacopoeia, not by the laboratory using it. What a laboratory must show is verification: that under its actual conditions the method still gives specific, accurate and precise results for the particular product being tested. Matrix effects, excipient interference and instrument differences all make this a real question rather than a formality.
“A method validated elsewhere is a promise. Verification is the proof it holds in your own hands.”
Verification covered specificity against known excipients and degradants, accuracy by recovery, and precision under repeatability and intermediate conditions with different analysts on different days. Where verification showed a compendial method could not resolve a product-specific impurity, an alternative in-house method was developed and fully validated instead.
The distinction between validating an in-house method and verifying a compendial one is maintained in the site's procedures and in the documentation supplied to partners.
Key facts
- Scope
- Compendial methods used for routine release
- Assessed
- Specificity, accuracy, precision under site conditions
- Where inadequate
- In-house method developed and validated
- Reference
- USP general chapter on verification of compendial procedures
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.