Specification

The limits, ranges or other criteria a quality attribute must meet for a material, intermediate or product to be accepted, set from characterization data and from clinical and safety experience. It is the final yardstick for whether a lot can be shipped. Japanese documents distinguish the specifications written in the marketing approval, in the specifications and test methods section, from internal limits a company sets for its own control, which may be tighter. When you see this word in a Japanese document, check which of the two it refers to, because only the approved specification is a regulatory commitment.