The pharmaceutical industry is heavily regulated beyond all other industries because many of the materials produced are potentially dangerous and can be severely toxic if not manufactured with proper care.

This level of regulation has led to the mandatory examination of all substances from starting materials to finished products.

Generally, this includes the proof of product stability, drug-release profiles, active pharmaceutical ingredient (API) form, API quantification, and product safety, for example sterility (for non-biological materials) and the presence of foreign materials.