E55 on Manufacture of Pharmaceutical Products


    Influence the Future of Pharmaceutical Manufacturing as a Member of ASTM's Newest Committee

    ASTM International, the leader in consensus standards development worldwide, has brought together a diverse range of stakeholders to create the standards that will help define future innovations in pharmaceutical manufacturing.

    ASTM Committee E55 comes together following an FDA overhaul of regulations governing drug manufacturing, the first such overhaul in 25 years. Recognizing that the pharmaceutical industry was in need of new processes and techniques in manufacturing, the FDA created "PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance." PAT was the first step in facilitating the development, implementation and regulation of manufacturing processes based on fundamental process understanding.

    Following the introduction of PAT, the needs of the pharmaceutical industry have evolved toward the definition and development of process-based “best practices” to advance a scientific approach toward process understanding and flexible manufacturing. To establish the foundation for PAT implementation, and to lend credence and general acceptance to the developed best practices, the FDA encouraged the pharmaceutical industry to take an active role in drafting these practices through consensus and broad-based stakeholder representation and input.


    ASTM International Standards Will Drive Innovation

    ASTM Committee E55 brings together hundreds of technical experts from the public and private sectors to write voluntary consensus standards that will help drive new innovations in pharmaceutical manufacturing and process control. As a member of Committee E55, you'll contribute to an industry-driven standards effort that will impact the pharmaceutical industry for generations to come. E55 members will develop standardized language and definitions of terms, recommended practices, guides, test methods, specifications, and performance standards for pharmaceutical application of process analytical technology.


    Get Involved

    Be part of this exciting initiative and play a leadership role in the new generation in pharmaceutical manufacturing. For more information visit the E55 homepage or contact Christine M. DeJong, Manager of Technical Committee Operations at +1-610-832-9736, e-mail: cdejong@astm.org.