Case Study
Vibha Biotech: A Vaccine Filling Suite Validated Ahead of Schedule
Client: Vibha Biotech Limited
The Challenge
Vibha needed a Grade A over Grade B filling suite validated to EU-GMP for an export contract. The regulator had already scheduled the inspection window, leaving no room for slippage.
Our Approach
We deployed a dedicated validation cell alongside execution. Each equipment IQ was closed within 48 hours of arrival, and OQ ran in parallel with mechanical completion using dummy media runs to compress the schedule.
The Outcome
The suite received EU-GMP approval on the first inspection with only one minor observation, which was closed within a week. The client shipped its first commercial batch two months earlier than originally planned.