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