WHO Guidelines - Qualification of temperature-controlled storage areas - Free PDF download

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Technical supplement to WHO Technical Report Series, No. 961, 2011

Annex 9: Model guidance for the storage and transport of time and temperature–sensitive Pharmaceutical products

What is ‘qualification’?

In the context of this series of Technical Supplements, qualification is an inspection and testing process used to establish that a piece of equipment or a physical installation is fit for purpose in the operational context within which it will be used. There are typically three stages in the process. Each stage must be fully completed before the next one begins.

Stage 1 (for equipment): Establish by laboratory testing under tightly controlled conditions that a specific item of equipment performs in accordance with the user requirements specification (URS). This is design qualification. Whilst design qualification demonstrates compliance with the URS and associated test protocols; it does not prove that the equipment will be suitable in a specific operating environment because the URS and the test procedures are unlikely to reflect the full range of operating conditions.

Stage 1 (for installations): Establish by documented inspection and testing that an installation5 that has been assembled in a specific location is fully in accordance with the user requirements specification and installation drawings. This is installation qualification.

Stage 2: Establish by further documented testing under controlled conditions that this equipment or installation is likely to perform as intended in the operating environment in which it will be used. This is operational qualification.

Stage 3: Carry out a final stage of documented testing to establish with a high degree of assurance that the equipment or installation, together with all associated systems, does indeed perform as intended under routine operating conditions. This is performance qualification.