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2005 · 09CompanyCompany Updates

Analytical laboratory begins routine testing

Six months after opening, Ergopharm's analytical laboratory in Vadodara has begun routine contract testing, running identity, assay and related-substances work for local formulators while the company's own quality system takes shape.

The first instruments installed were a pair of HPLC systems with UV detection, a Karl Fischer titrator and a dissolution bath. Modest by later standards, they were enough to establish the habits that still govern the site: every method written down before it is used, every result recorded against a specification, and every instrument calibrated on a schedule rather than when someone remembers.

We tested other people's products first. It taught us to write everything down for a reader who was not in the room.

Contract testing was a deliberate choice. Running other companies' samples imposed an external discipline early — turnaround commitments, documentation that had to satisfy someone else's auditor, and a steady stream of unfamiliar molecules that forced method development to become a routine skill rather than an occasional project.

The laboratory notebook conventions adopted in this period, later formalised under ALCOA+ data-integrity principles, remain the basis of how results are captured at the site today.

Key facts

Opened
Tandalja, Vadodara, Gujarat
First capability
Identity, assay, related substances, dissolution
Instruments
HPLC-UV, Karl Fischer, dissolution apparatus
Basis
Written methods, scheduled calibration, recorded results