Manufacturing and packaging operations are carried out according to the validated methods through systematically qualified machines with full documentation at all stages of operations.
The production sites follow the cGMP guidelines for environmental requirements of the manufacturing and packaging area, as well as comply with the EHS requirements.
Highly sophisticated HVAC systems are used to condition, monitor and supply clean air to the working zone according to the manufacturing zone concept, capture and control any dust, vapor, gas or fume generated, as well as treat re-circulated and/or exhausted air. Temperature and moisture level are maintained at the desired level through this system.
Design of the room and air-conditioning systems ensure:
- Prevention of contamination of the product.
- Protection of the environment.
- Protection of people.
- Prevention of the ingress of vermin, insects, birds etc.
There are different environmental zones maintained within the manufacturing area.
Training programs take place on a regular basis according to written plan. Personnel at all levels undergo general cGMP and Technical Training appropriate to perform their job satisfactorily.