Are safety tests conducted on biological products exempt from the GLPs?
Two kinds of safety tests are performed on human biological products. Those which are performed by the manufacturer prior to licensing, and those performed post licensing. The tests performed prior to licensing establish the basic safety profile of the product and they are covered by the GLPs. The safety tests performed post licensing are part of the required quality control assays, which permit the release of each batch of product. These tests are not covered by the GLPs. Safety testing of interstate biological products for use in animals is not covered by the GLPs since these products are not regulated by FDA. 18. Do the GLPs apply to veterinary drug and biological manufacturers even when the end products are strictly for veterinary use? The GLPs apply to animal drugs used on a prescription basis but they do not apply to interstate veterinary biologicals since these products are regulated by USDA. Intrastate veterinary biologicals, which are considered to be new animal drugs, are als
