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A new ASTM International standard could help pharmaceutical manufacturers support product quality through sampling done with certain instruments. ASTM International’s committee on manufacturing pharmaceutical and biopharmaceutical products (E55) developed the new standard (E3177), which covers both the sample from which data is taken and the sample that is taken for reference.
“This standard describes for the first time the considerations around sampling using process analytical technology, which most new pharmaceutical products rely on during development and manufacturing,” says ASTM International member Martin Warman, director, Martin Warman Consultancy Ltd. “The measurements taken directly on products or on material removed for laboratory analysis will support control and quality.”
Warman says that manufacturers could use the standard when developing and making products, while regulators could use it when reviewing documents for product approval as well as during inspections.
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