GMP Glossary & Definitions

Validation:

The term validation is used to demonstrate with written evidence that the item under consideration, e.g. process does what it purports to do. Validation includes but is not limited to: equipment, computer systems, production processes, cleaning procedures, facilities, utilities as well as analytical methods.

or

The procedure for establishing documented evidence that a specific system or facility is constructed and operates according to a predetermined set of specifications and guidelines.

Validation Master Plan:

The Validation Master Plan is a summary plan which communicates management’s expectations and commitments to be followed for the sites validation program including the responsibilities and is therefore a key document at a site. It describes the program to be conducted to get the items in question in a validated manner. The plan lists all of the validation activities to be completed, as well as the schedule for their completion.

 

Validation protocol:

A written plan stating how validation will be conducted while identifying specific acceptance criteria. For example, the protocol for a typical 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.

Validation or Qualification Plan:

A validation or qualification plan is a written plan stating how the particular Validation/Qualification will be conducted. This includes but is not limited to the individual tests to execute and the key and critical operating variables, equipment, number of repetitions as well as the acceptance criteria.

Validation or Qualification Report:

The Validation or Qualification Report concludes summaries and approves the relating result of the Qualification/Validation activities and data with respect to the protocol requirements and acceptance criteria.

Verification:

The term verification is broadly used in the GMP environment describe the act of reviewing, inspecting, testing, checking, auditing or otherwise establishing and documenting whether or not items, processes, services or documents conform to specified requirements.

Viable Contamination:

The term viable contamination is used when a product or a device is contaminated with any sort of living organisms.