QUALITY CONTROL
Quality Control Department is mainly concerned with analytical activity and verifying the quality of material being used in the manufacture of the product. The department mainly constitutes of Chemical /Instrumentation Analysts and Microbiologists. Materials that undergo analysis are API’s Excipients, Primary Packing Materials, Secondary Packing Materials & items that are used in the maintenance of the utilities. To check the quality of these materials, highly sophisticated, latest & modern equipments are used which are GLP & 21CFR compliant. These equipment’s work with password protection. Dep’t is mainly involved in Validation/Verification of Analytical Methods so that the right procedure is used to ascertain the quality of the material. Some of the equipment’s that are routinely used in the laboratory are Analytical Balances with high precision, UV/VIS Spectrophotometer, FTIR Spectrometer, TOC, HPLC, GC etc. along with other routine analytical equipments.
Analysts Microbiology :-
A very important department in any Sterile set up. Department is run by efficient Microbiologists. Activities like EVM, Sterility Test, BET, MLT and Maintenance of Cultures are carried out. Method Validation with respect to MLT, BET and Sterility are performed. Microbiologists are mainly responsible for the maintenance of classification of the area with respect to Viable & Non Viable particulate matter. Responsible to carry out the Media Fills to assure that the Process, Equipment, Area, Personnel and the Practices are all in compliance state to assure the product sterility.
QUALITY ASSURANCE
Quality Assurance is the backbone of any Pharmaceutical Industry. The Team consists of Pharmacists/Scientists/Regulatory Personnel. They 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”. The Quality Assurance team is mainly involved in maintaining the quality of the product manufactured, GMP, GLP, Training, Various Investigations of the product in question & Validations.