Abstract
The field of cellular therapies is rapidly expanding and with that expansion, a need for robust quality systems and regulations specific to these areas has arisen. The College of American Pathologists (CAP), AABB and the Foundation for the Accreditation of Cellular Therapy (FACT) have established quality standards for those participating in collection, processing, storage and distribution of these products. The FDA (Food and Drug Administration) regulates cellular therapy products as investigational new drugs or as licensed biologics, and the current Good Tissue Practice regulations as found in Code of Federal Regulations (21 CFR 1271) focus on assuring that these products are safe and effective. The future of cellular product production is one of expansion and discovery, and as novel products are found, regulatory oversight will adjust to ensure that the products manufactured meet strict criteria to prevent any safety issues as well as being effective for their intended use.
Published Version
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