Serum Institute of India has emerged as the largest exporter of vaccines and immuno-biologicals of the country with its products being exported to 138 countries across the globe, thus gaining worldwide recognition as a reliable source of quality vaccines which form part of the global vaccination programmes. This export performance has earned the company recognition as an Export and Trading House.
BEYOND 2000
As the future unfolds into the new millennium, Serum Institute will continue to share its philosophy of care across many more shores. We are now flanked by even bigger challenges which demand careful research and response. One major area of concern is the endeavour to prepare more heat stable vaccines. These would be of great value in our, and in other tropical climates where dependence on the 'cold chain' is a current constraint. The breakthrough could come by using newer delivery systems in vivo for ensuring the presentation of the vaccine to the cells of immune system for stabilising and releasing the antigen during an extended period of time.
Quality Assurance
Validation studies are mandatory for all equipment, all production processes and for analytical procedures in Quality Control. There is continuous monitoring of ancillary services such as water quality by LAL test, air-borne particulate matter by Met-one (model A-2408) / Climet (CI-7300) particle counter, live organism detection by air sampler (SAS-700), disinfectant efficacy, steam quality testing, air conditioning, refrigeration, sterile room integrity, and environment by settle plates and using other methods as per current GMP requirements. All this forms part of the regular routine. Spot checks are also instituted. Physical, chemical and biological methods are used to perform validation for the ovens, autoclave and tunnel. The data on every equipment, in the form of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) is maintained in the respective departments.
