ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Verification

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

NOTE: Monitoring and auditing methods, procedures and tests, including random sampling and analysis, can be used in the verification of the formal system.

Publication Source: ISO/TC209 Working Groups at 2001-03-31 – Committee Draft ISO/CD 14644-6 “Cleanrooms and associated controlled environments” – Part 6: Terms and Definitions

Verification

The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements. (also see: IQ (Installation Qualification))

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

See also: Installation Qualification (IQ)

Verification

(ISO) Confirmation, through the provision of objective evidence that specified requirements have been fulfilled.

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

Verification

Defined as “The process of evaluating the products of agiven phase to ensure correctness and consistency with respect to products and standards provided as input to that phase”.

Publication Source: GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach

Publication Date: 2010

Verification

Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Verification is confirmation for a particular use whereas Validation is confirmation for a more general and intended use.

Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition)

Publication Date: 2010

Verification

(ISO) (ASTM E 2500) A systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses all types of approaches to assuring systems are fit for use such as qualification, commissioning and qualification, verification, system validation, or other.

Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

Publication Date: 2008

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