Chemistry, Manufacturing and Controls terminology
54 terms
Numerical limits, ranges, or other suitable measures for acceptance of test results for a product, process, or control.
A defined procedure for testing a quality attribute (e.g., assay, impurities, dissolution) with specified conditions, system suitability, and acceptance criteria.
The substance or mixture of substances used in the manufacture of a drug product that is intended to furnish pharmacological activity. Same as drug substance.
An analytical test determining the amount or potency of the active ingredient in a drug substance or drug product.
Pyrogenic substances from Gram-negative bacteria that must be controlled in parenteral products, commonly tested via BET methods.