Validation

Documented evidence that a process, method, system or piece of equipment consistently does what it is intended to do. In Japanese GMP the requirement sits in the validation standard of the GMP enforcement notice, fully revised in 2013 as Japan prepared to join PIC/S, and explained in a guidance on validation concepts and worked examples published in 2014. The revised standard dropped retrospective validation and recognizes prospective and concurrent validation. Japanese uses the loanword; a native term meaning confirmation of appropriateness (妥当性確認) also appears, mainly for analytical methods. Qualification of equipment and utilities comes first, and process validation builds on it.