Quality, in every aspect of our business, has been a top priority since inception. Not only do the strictest quality standards apply to the products and raw materials, they are integral to all phases of plant operations, manufacturing, processing and procedures. In fact, the manufacturing process is designed and operated in accordance with IPEC/GMP guidelines for bulk pharmaceutical excipients.
We have in-house R & D and Quality Control Department (QCD) with Chemical, Physical and Microbiological analysis laboratories. QCD is well equipped for analysis of Pharma APIs & Excipients. Testings are carried out by well-qualified, trained and experienced staff.
Standard Analysis Procedure, Quality Plan, Standard Operating Procedures, Standard Hygiene and Cleaning Procedures, Standard Calibration Procedures, Training Programs are well documented and available with Quality Control Department. Issue and receipt of raw material, in-process and finished material are strictly controlled under FIFO method.
We make sure that inspection and testing of incoming, in-process materials and final products are carried out as per laid down relevant Quality Plans, Standard Operating Procedures & Standard Analytical Procedures.
Raw materials are inspected & tested for each consignment against relevant quality plan and released for production only after its approval by QCD. The in-process inspection activities are carried out regularly as per in-process Quality Plan.
Finished product is inspected as per relevant Finished Product Quality Plan. Finished product is finally released after it passes all quality and approval tests. Stability study of sample for self life is carried out as per the Quality Plan and sample from each batch is retained for the period of five years.
We regularly get our instruments (used for measurement and inspection) calibrated to ensure optimum test results. |