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.

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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.

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