Understanding the relationship between qualification and validation
Qualification and validation are closely related activities that provide evidence of suitability for an intended purpose. The distinction is useful when planning the work, assigning responsibilities and determining what the resulting evidence can support.
In practical terms, qualification commonly addresses facilities, utilities and equipment: whether they have been appropriately designed, installed and shown to operate and perform as intended. Validation addresses whether a defined process, procedure or method consistently achieves its intended outcome.
Consider a sterilisation process. Qualification of an autoclave establishes evidence about the equipment and its performance. Validation of a defined sterilisation cycle for specified load configurations establishes evidence about the process used to achieve the required outcome.
Successful equipment qualification alone does not demonstrate that every proposed load can be processed acceptably. The load, packaging, arrangement and cycle conditions all need consideration within the applicable validation approach.
The same relationship can be seen in cleaning. A qualified cleaning system provides a basis for controlled operation, while cleaning validation addresses the effectiveness of the defined cleaning process under the conditions assessed.
In my view, difficulties arise when these activities are planned separately without a clear connection to intended use. Equipment may pass its specified tests while an essential process requirement remains unaddressed.
The user requirements should therefore inform the qualification strategy, with the process requirements carried through to the relevant performance and validation activities. Acceptance criteria need to demonstrate the capability on which the subsequent operation will rely.
The evidence also has boundaries. Changes to equipment, operating ranges, materials or process configuration may affect its continued applicability. The assessment should establish whether existing evidence remains sufficient and what further work is needed.
Completion of a protocol is a milestone within that assessment. The report needs to explain the results, the significance of deviations and the conditions under which the system or process can be used.
The practical objective is a connected body of evidence supporting reliable operation throughout the lifecycle.
Background and scope
EU GMP Annex 15, sections 1 to 5, 10 and 11. These provide background on planning, qualification, requalification, cleaning validation and change control. The restart discussion is a practical application of these principles.