Non-PRO English to French Tech/Engineering Medical: Pharmaceuticals qualité pharmaceutique

Specifications are critical quality standards that apply to excipients, drug substances, components, and/or drug products. The acceptance criteria for specifications are commonly established by a compendial monograph or sometimes, by the manufacturer themselves. Specifications vary, depending on the type of product that’s examined, and the specific test that’s being performed. Specifications apply to the finished drug product’s release, as well as to the entire duration of a product’s shelf life. Specifications can be qualitative, or quantitative, and sometimes both.