The Public-Private Synergy
Two apparently unrelated stories converge in the feature section this month. First, there are the standards developed by ASTM International Committee E55 on Manufacture of Pharmaceutical Products, which are beginning to impact manufacturing design processes in the pharmaceutical industry. The other is coverage of the April ASTM board meetings in Washington, D.C., during which board members and staff fanned out across the U.S. capital to meet with D.C.-based representatives of government and industry.
Formed in 2003, Committee E55 has been pursuing greater efficiency and quality in drug manufacturing through standardization. Prior to the existence of the committee, the industry had been using traditional manufacturing methods that, while clearly producing quality pharmaceuticals, were not taking advantage of opportunities for improvements in efficiency, process control and safety.
One reason the drug industry was not embracing manufacturing innovations such as process analytical technology was that the U.S. regulatory environment was not conducive to this type of change. In recognizing this, the U.S. Food and Drug Administration launched an initiative to help introduce process improvement. As part of the initiative, the FDA and industry stakeholders agreed to use ASTM International as the forum for developing standards that would enable the shift to more efficient production techniques.
In the article "Building a Road Map," we explore a trio of E55 standards, two of which are changing the way pharmaceutical manufacturers design their processes. The FDA has joined other stakeholders in the development of these documents and now regularly uses a third standard to help ensure that data coming to the FDA from manufacturers accurately represent the product’s properties.
By now you may have guessed how it is that an article on pharmaceutical manufacturing and another on the recent board meetings and outreach visits in Washington, D.C., are, on some level, about the same idea. Both highlight the strong and mutually beneficial relationship ASTM has with both government and the industries regulated by government. "ASTM in Washington, D.C." describes the wide-ranging effort undertaken in April to give ASTM board members and government and nongovernment entities a chance to meet and discuss common needs. The ultimate result of this public-private synergy is exemplified by work such as that of Committee E55, which can help all of us feel more and more assured of the safety of the products we use.