New Paradigm of Building Quality during Manufacture – Challenges with Biological Products
Posted on November 7,2017
Introduction Biological products, biologicals or biologics are important class of drugs used in diagnosis, prevention and treatment of disease. These products are made from natural biological sources, including humans, animals and microorganisms, often made in cells, tissues, microorganisms and whol...
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Related Topics and Keywords
and Cosmetic Act, Biological products, biologicals, biologics, Biologics Control Act of 1902, Biologics Quality & Regulatory Consultants, Conventional Quality Paradigm, drug, FD&C Act), FDA, Federal Food, microorganisms, natural biological sources, PHS, Public Health Service Act, Pure Food and Drugs Act in 1906, Rajesh K. Gupta, US Food & Drug Administration