Quality Assurance, Quality Control, Instrumentation Area
The Quality Assurance (QA) system is an integral part of a healthcare product manufacturer. The role of the Quality Assurance is to co-ordinate the development and maintenance of the company’s Quality procedures and systems. There are standard operating procedures (SOP’s) for all activities including Raw material procurement, Production, Quality Control, Material Management, Engineering, Environmental Controls, House Keeping and Sanitization. Quality Assurance ensures that these procedures are adhered to and the records of the same are maintained. QA ensures that necessary measures and relevant tests are undertaken before the products are released for use or supply. A major portion of the analytical testing done on the raw materials and finished products is accomplished in-house and is carried out by qualified staff. The analytical processes are under the control of qualified technical staff. The Quality Control laboratory is equipped with analytical instruments such as HPLC (brands complying with the cGMP and CFR requirements), UV Spectrophotometer, Dissolution Apparatus, FTIR et al. The microbiology department is equipped to carry out the necessary microbial tests that are an integral part for products involving the use of gelatin. The microbiology department is equipped with double door high pressure steam sterilizer (Autoclave), BOD incubators, LAF and a TOC analyzer to assure the highest quality of water. Quality is mandated by the management and assured by the technical staff at every level of operation. The effectiveness and applicability of Quality Assurance is regularly monitored through an internal audit system at regular intervals. Water System Considering the criticality of the water quality the facility is equipped with a State of the art Water system meeting USP guidelines.
