Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products

    Staff Manager: Travis Murdock 610-832-9826

    Subcommittees and Standards

    Standards under the jurisdiction of E55

    Each main committee in ASTM International is composed of subcommittees that address specific segments within the general subject area covered by the technical committee. Click on the subcommittee links below to see the title of existing standards for each subcommittee. Then, click on the resulting titles to see the standard's scope, referenced documents, and more.

    E55.01 Process Understanding and PAT System Management, Implementation and Practice
    E55.03 General Pharmaceutical Standards
    E55.04 General Biopharmaceutical Standards
    E55.05 Lyophilization
    E55.06 Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products
    E55.90 Executive
    E55.91 Terminology
    E55.94 Outreach and Education
    E55.95 Roadmap for Standards Development