Revising the 1987 industry guideline: The development of FDA's guidance on aseptic processing

FDA, led by CDER's Office of Compliance, is developing its guidance document regarding aseptic processing to update the 1987 industry guideline Sterile Drug Products Produced by Aseptic Processing. The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committee on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group. The working group obtained input from 50 aseptic filling facilities and data for 600 individual media fills. The working group's recommendations will be considered in the development of this CGMP guidance by FDA.