Quality Control of Immunobiologicals (Vaccines and Sera)
imported, produced indigenously for domestic use or for exports.
Advice to NRA on technical matters and interaction with
manufacturers for improvement in the quality of Immunobiologicals
including Post Approval Changes.
Scrutiny of manufacturer's Summary Lot Protocols and evaluation
of CMC Module-III of manufacturing and quality control of
Immunobiologicals.
Pre-licensing and Post-Licensing testing for assuring consistency of production
Development, evaluation, establishment and implementation of testing procedures
Review of reports on quality defects & provision of advice on withdrawals of vaccines & sera.
Research and development in the field of quality control of Immunobiologicals.