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ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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Qualification
The process of demonstrating whether an entity is capable of fulfilling specified requirements.
Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition)
Publication Date: 2010
Qualification
(ISO) The process to demonstrate the ability to fulfill specified requirements.
Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems
Qualification
(MHRA) Action of proving that any instrument or equipment works correctly and actually leads to the expected results. The word “validation” is sometimes widened to incorporate the concept of qualification.
Publication Source: GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition)
Publication Date: 2010
Qualification
(ICH Q7) Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
Qualification
Process of demonstrating whether an entity – activity or process, product, organization, or any combination thereof – is capable of fulfilling specified requirements.
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
Qualification
Process of demonstrating whether an entity is capable of fulfilling specified requirements.
NOTE: in the context of meeting regulatory requirements, ‘qualification’ implies adherence to strict documentation requirements, reviews and approvals.
Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance
Publication Date: 2005
Qualification
(ICH Q3A (R2)) The process of acquiring and evaluating data that establishes the biological safety of an individual impurity or a given impurity profile at the level(s) specified.
Publication Source:
Qualification
(ICH Q3B (R2)) The process of acquiring and evaluating data that establishes the biological safety of an individual degradation product or a given degradation profile at the level(s) specified.
Publication Source:
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