First sterile export consignment dispatched
Ergopharm has dispatched its first export consignment of aseptically filled ampoules, following completion of the sterile block's qualification and media-fill programme.
The consignment is the point at which several years of work becomes a shipment: a facility designed in 2006, a sterile block begun in 2011 and qualified in 2012, an aseptic simulation programme run to its acceptance criterion, and a batch released against a full specification with sterility and endotoxin results in hand.
“Seven years from a laboratory in Tandalja to a sterile consignment leaving the gate.”
The packs carry the same documentation discipline as the process that made them — a certificate of analysis referencing the released specification, batch and expiry printed on every carton, and shipping documents naming the licensed distributor receiving them. Verification of that distributor's authorisation preceded the order rather than followed it.
Registration in the destination market, where required, is held by the partner. Ergopharm makes no claim of approval by any national authority.
Key facts
- Product
- Aseptically filled ampoules
- Preceded by
- Qualification and a completed media-fill programme
- Released against
- Full specification including sterility and endotoxin
- Recipient
- Licensed distributor, authorisation verified before supply