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@article{190233,
        author = {Tanmayi Prakash Adhav and Dr Pritam Dube and Dr Laxmikant Borse},
        title = {Regulatory Guidelines for Vaccines and Sera},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {8},
        pages = {2371-2383},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=190233},
        abstract = {These are the biomedical products that works to build up to protect human body from foreign materials. The products which are used for immunization are known to be immunizing agents. Immunoglobulins and sera provides passive immunity by transferring ready made antibodies produced by an animal or person who has received active vaccination. Serum is a concentrated and purified product of the serum of horses or rabbits that have received active vaccination against a particular antigen. Occasionally it exhibits an allergic reaction right away. Both vaccines and sera plays a crucial role for avoiding and treating infectious disease, strict regulatory compliance is required to guarantee their products are free from contamination are effective and safe with quality product. On the other hand rules are set by the organizations like the world health organization (WHO), U.S Food and Drug Administration (FDA), and the Central Drugs Standard Control Organization (CDSCO) in India, this research determines the national and international regulatory structure controlling vaccines and sera. There are different regulatory process steps which include preclinical research, clinical trials, good manufacturing practices, and post marketing surveillance. Current progress in regulatory science generate a emergency use authorization approval processes and pharmacovigilance system which are under consideration. Along with the obstacles in bonding with global standards, the initiative offers creative regulatory approaches to enhance accessibility and guarantee public health and safety.},
        keywords = {Immune response, vaccinations., sera},
        month = {January},
        }