Infrastructure

The premises is well maintained with natural and artificial light and effective ventilation. Plant is designed to have logical and unidirectional movement of men and materials. The production layout of all dosage form is common. In the production layout, there are separate cubical for day store, manufacturing, filling and quarantine. The material movement and equipment placement is orderly and logical to maintain cleanliness in the area, and to avoid the risk of mix-ups, prevent possibilities of contamination and cross contamination. The ground floor structure of building is constructed of RCC. The flooring is of Kotah stone, mirror polished with epoxy joints. Wall and ceiling are painted with weather proof paints. In the critical processing areas and aseptic area, wall and floors are epoxy painted. The ceiling height s 10 Feet from the floor in entire plant. Glass windows are installed in each department.

EQUIPMENT

All the manufacturing equipment or instrument, which come in direct contact with product made of S.S.316 or suitable inert material, which will not adversely affect product quality. At the time of product changeover the machine / equipment of manufacturing, compression, filling and coating are dissembled and cleaned thoroughly as per respective machine cleaning SOP. Equipment clearance is obtained from Quality Control at the time of product changeover. In case of product changeover, line clearance is obtained from Quality Assurance Dept. The liquid oral manufacturing tanks are equipped with temperature indicator and pressure guage. In all other equipment wherever required, temperature guage / indicator and pressure guage of suitable range are installed. All the processing equipment and accessories are qualified at defined frequency. In the Quality control, sophisticated instruments like UV, spectrophotometer are installed with printer facility. A separate microbiology dept. with separate incubator room, sterility test area, media preparation room and microbial limit test area is available in Quality control.