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.