Glossary

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.

(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.

(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.

(ISO) The process to demonstrate the ability to fulfill specified requirements.

The process of demonstrating whether an entity is capable of fulfilling specified requirements.

(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.

(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.

Those batches produced by the Receiving Unit to demonstrate its ability to reproduce the product.

A Test Plan for use in Qualification activities.

An individual detailed document that describes the system under consideration, testing plans, acceptance criteria and test results that ensure that a system is installed and operates in accordance with predetermined specifications.

An outline of the approach to be taken in assessing the qualification efforts, determining the extent and boundary limits of the qualification effort, and execution and ownership for the project’s qualification activities.

Report summarizing the results of protocol execution.

(IEEE) Formal testing, usually conducted by the developer for the consumer, to demonstrate that the software meets its specified requirements.

(ICH Q3B (R2)) A limit above (>) which a degradation product should be qualified.

(ICH Q3A (R2)) A limit above (>) which an impurity should be qualified.