Pharmacopoeial reference standards programme established
Ergopharm has established its reference standards programme, procuring official pharmacopoeial standards and qualifying its own working standards against them under a written procedure.
Every assay result is ultimately a comparison against a reference. If the reference is wrong, so is everything measured with it, and no amount of instrument qualification will reveal the error. Official standards issued by the pharmacopoeias are therefore treated as the anchor of the whole analytical system.
“Every number the laboratory issues is a comparison. Get the reference wrong and you get everything wrong.”
Because official standards are expensive and supplied in small quantities, routine testing uses working standards prepared in-house and characterised against the official material for identity, assay and, where relevant, water content. Each working standard carries a qualification report, an assigned potency and an expiry, and is requalified on a defined interval.
Standards are stored under the conditions their certificates specify, with access controlled and use logged, so that a questioned result can be traced to the exact standard vial used.
Key facts
- Anchor
- Official pharmacopoeial reference standards
- Routine use
- In-house working standards characterised against them
- Each carries
- Qualification report, assigned potency, expiry
- Control
- Defined storage, restricted access, use logged
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.