|Browse All Terms|
|Beginning With||By Language|
|A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All||
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
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
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
Do you have a term that should be included in the glossary?
Submit a term for review