A specification is a defined set of acceptance criteria — including tests, analytical methods, and numerical limits — that a drug substance, drug product, raw material, or in-process sample must meet to be considered acceptable for its intended use. Specifications are established based on scientific understanding of the product, process development data, clinical experience, and regulatory guidelines such as ICH Q6B for biotechnological products, and are formally included in regulatory submissions as part of the Chemistry, Manufacturing and Controls (CMC) documentation. They serve as the primary tool for batch release decisions, stability assessments, and comparability evaluations in GMP-compliant manufacturing.
