ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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User Requirement Specification (URS)

A description of the requirements of the facility in terms of product to be manufactured, required throughput and conditions in which the product should be made.

Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems

Publication Date: 2007

User Requirement Specification (URS)

A requirement specification that describes what the equipment or system is supposed to do, thus containing at least a set of criteria or conditions that have to be met.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

User Requirement Specification (URS)

Generally the first in a series of specification documents. It provides a high level description of the user's expectation of the project scope, with emphasis on product parameters and process performance parameters.

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

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