First commercial batch released
Ergopharm has released its first commercial batch of finished product, an oral solid dose manufactured, tested and released entirely within the Vadodara site.
The batch record ran to several hundred pages: dispensing weights, in-process checks at every stage, line-clearance sign-offs, packaging reconciliation and the full analytical release panel. It was reviewed page by page before the authorised person signed the release, and it set the expectation that no batch ships on a summary.
“Nothing about that first release was fast. That was the point.”
Release testing covered identity, assay, uniformity of dosage units, dissolution and related substances against the finished-product specification, with results assessed against defined limits rather than against a general impression of acceptability.
Retained samples from the batch were placed on the site's first ongoing stability study, beginning the practice of keeping one batch per product per year under long-term storage.
Key facts
- Form
- Oral solid dose
- Release
- Against finished-product specification
- Review
- Full batch record, page by page
- Retention
- Samples placed on ongoing stability