Salient features of the facility are :
- Unidirectional Flow of Men & Materials.
- High Level of Product Protection from contamination & cross-contamination
- Upcoming…..Use of gravity/vacuum transfer systems for the product movement and high degree of automation for product & personnel safety.
- HVAC System designed to meet the cGMP requirements , e.g. Pressure Differentials, Filtration Rating, Temperature & Humidity control.
- Men – material flow : Uni linear man and material movement for the starting and finished products ensure prevention of mix-ups & cross contamination.
Validation :
Validation activity is a journey and not a destination throughout the lifecycle of a product, process, equipment and facility. Validations are carried out as per defined procedure for processes, new formulas, changes to the existing procedures. Re-Validations are carried out as per schedule to ensure that the processes are achieving the intended use & of highest quality.
Utilities :
- HVAC System
- Purified Water System
- Compressed Air System
- Steam Boiler & Supply System
- Captive Power Generation & Supply System (D.G. Set)
- HT / LT Power Supply
Capacity & Capabilities :
We offer commercial OTC / Generic finished products & contract manufacturing services as per cGMP practice in solid oral dosages.
