ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Validation

Establishing documented evidence that the system does what it purports to do.

Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision

Publication Date:

Validation

The action of proving, in accordance with the principles of GxP, that any procedure, process, equipment material, activity or system actually leads to the expected results.

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

Publication Date: 2010

See also: Qualification

Validation

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. FDA Guidelines on General Principles of Process Validation, May 1987.

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

Publication Date: 2007

Contrast with:

Validation

(ICH Q7) A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.

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

Publication Date: 2004

Validation

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.

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

Validation

Establishing documented evidence that the system does what it purports to do.

Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision

Publication Date:

Validation

The action of proving, in accordance with the principles of GxP, that any procedure, process, equipment material, activity or system actually leads to the expected results.

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

Publication Date: 2010

See also: Qualification

Validation

Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. FDA Guidelines on General Principles of Process Validat

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

Publication Date: 2007

Contrast with:

Validation

(ICH Q7) A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.

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

Publication Date: 2004

Validation

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.

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

Validation

Defined generically, a process to determine that a system or process is fit for the intended use. In ASTM 2500-07 and GAMP 5, verification in concert with design review activities fulfill this objective.

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

Publication Date: 2010

Validation

-0

Publication Source: ISPE Baseline® Guide, Vol. 3: Sterile Product Manufacturing Facilities (Second Edition)

Publication Date: 2011

See also: Process Validation

Validation

For the purposes of this Guide (ISPE GPG Assessing the Particulate Containment Performance of Pharmaceutical Equipment) the term “validation” is used only in relation to quantitative, analytical methods and is not meant to denote a cGMP-related context

Publication Source: ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)

Publication Date: 2012

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