Zdrowie i gospodarka · 20/01/1995

Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Amendment of Certain Requirements for Finished Pharmaceuticals

The Food and Drug Administration (FDA) is revising certain requirements of the current good manufacturing practice (CGMP) regulations for finished human and veterinary pharmaceuticals. The changes include clarifying the degree of discretion provided to manufacturers to determine whether separate or defined areas of production and storage are necessary, clarifying the standard used to determine the degree of scrutiny necessary to check the accuracy of the input to and output from computer systems, exempting investigational new drug products from bearing an expiration date, permitting the use of a representative sampling plan for the examination of reserve samples, and clarifying the manufacturer's responsibilities regarding batch records during the annual evaluation of drug product quality standards. These revisions will reduce regulatory burdens.