GMP Glossary & Definitions

Unidentified Impurity:

An unidentified impurity is defined as an Impurity that is identified solely by qualitative analytical properties, e.g. chromatographic retention time.

Unplanned Maintenance:

Unplanned Maintenance is any maintenance, which must be conducted on short notice because of an occ0orence, also known as breakdown maintenance or repair.

User Requierment Specification (URS):

The user specifications are the specifications written down in a document describing in detail the requirements of the customer (user) with which the e.g. product, materials, process or computer system must confirm.