The premises is located, designed, constructed and maintained, to suit the production of tablet formulations, following current Good Manufacturing Practices (GMP). The layout design is aimed to minimize the risk of error and permit effective cleaning and maintenance, in order to avoid contamination, mix-up, build up of dust or dirt in general and to have a uni-flow pattern for the products, as well as for the raw materials.
Different areas are physically segregated. Change room and lockers are provided to workers. Standby generators are provided in the unit for immediate and uninterrupted power supply. AHU’s are provided in all process areas and storage areas are also environmentally controlled.
Storage area has sufficient capacity to allow orderly storage of raw, packaging and finished materials. These areas are properly ventilated and have proper light arrangements. The raw material stores and finished goods stores are environmentally controlled. Separate sampling and dispensing area’s are provided with air handling units.