ASTM Pharmaceutical Standards

ASTM Pharmaceutical Standards

ASTM pharmaceutical standards provide the foundation for quality, safety, and performance in drug development and manufacturing.

They support every stage of the pharmaceutical lifecycle, from raw material testing and laboratory practices to finished product evaluation and packaging integrity.

By creating consensus-driven methods that are globally recognized, these standards ensure that medicines meet rigorous benchmarks for purity, efficacy, and consistency.

Developed through the work of ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products, these standards cover critical areas such as process control, analytical methods, biopharmaceutical manufacturing, and quality management systems.

Together, they offer a reliable framework that regulators, manufacturers, and testing laboratories depend on to ensure patient safety and industry compliance.

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Digital Access to Pharmaceutical Standards

ASTM’s pharmaceutical standards program is continuously updated to reflect the latest advances in technology, science, and regulatory expectations.

New standards are regularly developed to address emerging challenges such as continuous manufacturing, advanced analytical techniques, and personalized medicine.

Through ASTM Compass®, professionals gain access to the most current versions of these standards, along with collaboration tools that keep teams aligned across the pharmaceutical supply chain.

In an industry where precision and safety are non-negotiable, ASTM pharmaceutical standards provide the essential framework for delivering medicines that patients and healthcare systems can trust.