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How does biological agent type affect regulatory standards?
While the production of most biologics are subject to the same baseline regulations (US Food and Drug Administration Code of Federal Regulations Title 21 Part 610) regarding quality, consistency, safety, and record keeping, certain types of agents are subject to additional regulatory parameters. For example, numerous additional regulatory guidelines exist regarding human blood and blood-based products (including immunoglobulins), including donor eligibility criteria, as well as for allergenic products and products manufactured for diagnostic laboratory testing. Additionally, individuals who are a part of workflows involving vaccines, viruses, and spore-forming organisms require either additional protective equipment and/or must be segregated from other workflows for at least one day. Finally, specific regulatory criteria such as storage temperatures and conditions will vary from individual agent to agent, especially for more sensitive or perishable biologics such as fluids, vaccines, and blood.
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