Quality control laboratory established

The new laboratory supports the two release-critical questions that sit behind every dispatched pack: is the product what the label says it is, and is it present at the declared strength. Identity confirmation and assay determination are now performed on site, alongside the analytical work needed to underpin the Certificate of Analysis that accompanies each finished batch. Bringing these methods in-house shortens the path between manufacture and Qualified Person release, and keeps the analytical record close to the Batch Manufacturing Record it supports.

“In-house identity, assay and stability testing lets Ergopharm release every batch against data it generates, traces and stands behind.”

Stability testing is the second pillar of the facility. Following the ICH Q1A(R2) framework, samples are held under defined conditions - long-term storage at 25 C/60% RH, intermediate at 30 C/65% RH and accelerated at 40 C/75% RH - so that shelf-life and storage statements rest on Ergopharm's own study data. As an export manufacturer serving markets across the ICH climatic zones, a dedicated stability programme means expiry dating and handling instructions can be defended with results generated and retained internally.

For distributors, the change is practical rather than promotional. Batches carry a Certificate of Analysis backed by testing that Ergopharm can trace, explain and stand behind, with deviation and out-of-specification handling managed within a single quality system. The laboratory is built to operate to ALCOA+ data-integrity principles, so analytical records are attributable, legible and contemporaneous from the moment a result is captured.

For the portfolio, the laboratory establishes the analytical foundation on which future products and processes will be qualified. It gives Ergopharm direct ownership of the data that defines each product's identity, strength and shelf life - a prerequisite for the disciplined, prescription-only manufacturing the company sets out to deliver from its Vadodara site.