Skills We Got
The team constitutes of well, qualified and experienced pharmacists who are well aware of cGMP to manufacture a quality products. The team has handled all types of sophisticated formulations like Powder Filling, Lyophilized Products & Pre Filled Syringes. In addition to these the team is well experienced in the processing of Ampoule & Vial Liquid Formulations. Since the team is handling the high end products, they have the hands on experience to handle the sophisticated processing machines which involves of CIP/SIP vessels, Washing Machines, Sterilizing Tunnel, Filling Machines, Lyophilizer and the Pre Filled filling Machines. All the equipment that are used in the process are well qualified and cGMP compliant. As all the products manufactured are sterile preparations, the team is well aware of Aseptic connections and Aseptic behavior which is of paramount importance in the manufacture of any sterile product.
Mechanical, Electrical, Electronics & Mechatronics Engineers constitute the Maintenance Department which takes care of the entire Utility & the Equipments in Production of the Plant. The team is mainly responsible for the quality of the product by providing required quality of Purified Water, Water for Injection, Compressed Air & Nitrogen. The well qualified team has a thorough knowledge of Air Handling Units and Air Balancing in the critical & non critical areas which plays a very pivotal role in maintaining the ΔP of each classified area. The boilers & the cooling towers are also maintained by the Engineering team to provide the quality steam & cooled water circulation so as to get a quality utility for the boilers and chillers.
Quality Control Team
Qualified Pharmacists, Scientists, Microbiologists and Analysts constitute the Quality Control Team. They are the key personnel to certify that the product is complying with the specification and is suitable for the intended use of medication. The products that are manufactured in the premises undergo complete scrutiny of the quality parameters by using sophisticated instruments which are well qualified and are 21 CFR compliant. These equipments are periodically calibrated to certify their suitability of usage. On the Microbiological aspect, the products are tested and certified for their compliance to Sterility, Microbiological Bio load, Endotoxin & Particulate matters. Microbiologists carry out in process tests in all the classified areas for Environmental monitoring, viable & Non-viable counts and to certify that the area is suitable and compliant for the desired classification and the area is suitable for the manufacture of the sterile products.
Quality Assurance Team
Quality Assurance is the back bone any Pharmaceutical Industry. The Team consists of Pharmacists /Scientists /Regulatory Personnel. They are the personnel who certify “that the product is thoroughly reviewed with the executed batch record and confirm that the product was manufactured under GMP conditions. They also confirm that the sterilization, laboratory records, in process records and other data pertaining to the product confirm the product to be acceptable for release and distribution to the market”. All the products are released to the distribution by Qualified Person (QP) who is an authorized personnel certified by Drugs Control Dept of the State. The Quality Assurance team is mainly involved in maintaining the quality of the product manufactured, GMP, GLP, Training, Various Investigations of the product under question & Validations.