Skip to main content

Drug Substance Specification

Meaning

Drug substance specification refers to the comprehensive set of quality standards, tests, analytical procedures, and acceptance criteria that a bulk active pharmaceutical ingredient (API) must meet to be deemed acceptable for its intended use in drug product manufacturing. This legally binding document defines the identity, purity, strength, and other critical physical and chemical properties of the raw drug material. Strict adherence to the drug substance specification is a fundamental requirement of Good Manufacturing Practice (GMP) to ensure the consistent quality and safety of the final medicinal product. Any batch of drug substance that fails to meet any of the established criteria must be rejected.