|Another Public-Private Sector Standardization Partnership
With its emphasis on the R&D that has resulted in the creation of new, lifesaving medicines, the pharmaceutical industry has, by its own admission, not taken advantage of well-established manufacturing assessments for the production of those drugs. While many other manufacturing sectors such as food, petrochemical, semiconductor and aerospace have used process analytical technology to reduce production cycle times and waste, increase automation, improve efficiency, and manage variability, pharmaceuticals have long been produced to tried-and-true, but not state-of-the-art, processes. The result was up-to-spec drugs that were also costing pharmaceutical companies more money and time to produce than necessary.
The Food and Drug Administration, which regulates the pharmaceutical industry in the United States, opened discussion of this issue in 2001, when the FDA Science Board met to consider the industrys manufacturing practices. The result was the formation of a Process Analytical Technology Subcommittee within the FDAs Advisory Committee for Pharmaceutical Science and later publication of draft guidance for industry, PAT A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance.
The stage was set for a public- and private-sector cooperation in standards development for the pharmaceutical industrys use of process analytical technology in drug manufacture, and the FDA and industry turned to ASTM International. After organizational meetings in late 2003, the ASTM board of directors approved the creation of new Technical Committee E55 on Pharmaceutical Application of Process Analytical Technology in January.
The FDA, like many other U.S. government agencies, is not new to participating in ASTM standards development as a partner with an industry it regulates. The FDA already has a presence on ASTM committees such as F04 on Medical and Surgical Materials and Devices and F29 on Anesthetic and Respiratory Equipment. The feature section of this issue of SN highlights new Committee E55, with articles from both the FDA and a U.K. pharmaceutical supplier on the need for these standards. Although partially sparked by the actions of one U.S. regulatory agency, the committees work has attracted international participation in the nascent development of standards that can help improve manufacturing processes for the pharmaceutical industry.
Editor in Chief
Copyright 2004, ASTM International