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.