Great care and research has been conducted to make sure that the smallest detail is not overlooked in compliance with:

· cGMP (Current Good Manufacturing Practice) in manufacturing, processing, packing and handling of drugs in accordance with parts 210 and 211 Code of FDA.  · Central AP-Water (Aqua Purifica) generation and independent sub-loops for each production unit, as practiced in the most modern pharmaceutical plants of the world. · CWW (Contaminated Waste Water) treatment and plumbing in accordance with part 211 Code of FDA.

· Manufacturing Equipment carefully selected in accordance with the SUPAC-IR guidelines and, more importantly, validation of all production units.  Most advanced, validated and automated equipment is used to avoid human errors in production. Production machinery is state of the art, computer controlled and output is electronically batch recorded for careful quality control and documentation purposes.

 

· Hygienic HVAC Systems (Heating, Ventilating, and Air Conditioning), in accordance with the highest EUROVENT / CECOMAF standards for pharmaceutical production.   Independent ventilation system for each production unit, creating negative pressure to the environment. · Computer Controls using advance BMS (Building Management Systems) for controlling, optimizing and electronic recording of air quality in the production zones.

· Advanced Materials Handling methods and independent material flow.  Separate personnel flow have been entrenched in the overall design.

. Meticulous execution of Cleanroom details, in compliance to the highest requirements of cGMP.