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What is Raw Material Testing?

Pharmaceutical products are manufactured by combining different materials such as the active ingredient and inactive ingredients. Each of the ingredients is evaluated prior to use in production. The evaluation includes tests such as identification, assay for potency, assay for impurities, or objectionable organisms. This testing is referred to as raw material testing.

Many of the common ingredients are listed in the United States Pharmacopeia (USP) and have a defined panel of tests that must be conducted depending on the material. The USP is an organization made up of representatives of the US Government, academia, and industry.

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