ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products was formed in 2003. E55 meets twice each year, in May and November, with about 50 members attending three days of technical meetings (every 3rd to 4th meeting of E55 is held outside of the United States). This Committee addresses issues related to process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. Stakeholders include manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia. The Committee, with a membership of 189, currently has its standards published in the Annual Book of ASTM Standards, Volume 14.01. E55 has 3 technical subcommittees that maintain jurisdiction over these standards. Information on this subcommittee structure and E55's portfolio of approved standards and Work Items under construction are available from the List of Subcommittees, Standards and Work Items below.