DEFRATAJ is manufactured at Taj Pharma's purpose-built oral solids facility in Sarigam GIDC, Gujarat - a WHO-GMP certified plant designed around segregated production suites, robust environmental control and end-to-end batch traceability.
Plant Layout #
- Dedicated dispensary with negative-pressure sampling booths and laminar airflow weighing units.
- Segregated wet and dry granulation suites with online dust extraction.
- Compression area with high-speed rotary presses qualified for dispersible tablet hardness, friability and disintegration profiles.
- Blister and bottle packaging halls with checkweighers, vision-system online inspection and serialisation-ready coding.
- Independent QC laboratories for chemical analysis (HPLC, UV, IR, KF) and microbiology.
Environmental Controls #
HVAC systems maintain Grade D / ISO 8 conditions in production areas, with classified airlocks separating each suite. Temperature, relative humidity and differential-pressure data are continuously logged through a 21 CFR Part 11 compliant Building Management System.
Process Validation #
All DEFRATAJ strengths are manufactured under validated processes following a three-batch concurrent validation protocol, with continued process verification thereafter. Critical Process Parameters (CPPs) are linked to predefined Critical Quality Attributes (CQAs).
Batch Uniformity Assurance #
Each batch is sampled at start, middle and end of compression and packaging runs. Results are reviewed against statistical control limits and trended over time, providing objective evidence of batch-to-batch consistency.