Glossary

A testing technique using valid (normal or expected) input values or conditions.

(NBS) Test data that lie within the domain of the function represented by the program.

To prove to be valid.

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

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

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.

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.

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.

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

(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.

SO 9000-3, the international guidelines for the development, supply, and maintenance of software differentiate between verification and validation.

Listing of a series of events within the life of a direct impact manufacturing system which are identified as important to create or maintain product quality over the life of the direct impact system.

Listing of a series of events within the life of a direct impact manufacturing system which are identified as important to create or maintain product quality over the life of the direct impact system.

The documented plan for qualification of a facility, or part of a facility that identifies the layout of the operation, the associated utilities and systems, the equipment, and the processes to be validated. The validation master plan also provides preliminary information as to the extent of the qualification and validation (IQ, OQ, PQ), required documentation, SOPs, acceptance criteria, and responsibilities. Validation Master Plans should also establish the cross reference of qualification projects by product, system, discipline, etc.

A high level document, which establishes an umbrella validation plan for the entire project and is used as guidance to the project team for resource and technical planning.

(PDA) A document which describes the overall strategy and responsible parties for validating a system within its operating environment.

A Quality Plan for a project with validation requirements, which describes the overall strategy for validating a system within its operating environment, seen from the user’s perspective. Sometimes called a Validation Plan or a Validation Master Plan.

A written plan describing the process to be validated, including production equipment and how validation will be conducted. Such a plan would address objective test parameters, product and process characteristics, predetermined specifications, and factors, which will determine acceptable results.

A pre-approved Test Plan for use in validation activities.

(ICH Q7) A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, and test data to be collected, number of validation runs, and acceptable test results.

(FDA) A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.