The installation, operational, and performance qualifications are three separate and complete protocols that reference each other and are performed and evaluated in a definite sequence. Each protocol serves a distinct function interrelated to the design, construction, and eventual use of the system. In general, the concepts outlined in this paper are carried out, to some degree, on most projects. However, these procedures are absolutely mandatory in order to claim compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) requirements. Further, to be in cGMP/GLP compliance, it is required that all such procedures be documented and that the documentation be rigorously reviewed and approved by the responsible parties, usually defined by the end user of the space. If the validation/commissioning programme is planned and implemented as an integral part of the project, the additional time required will be minimised. The benefits of a properly commissioned HVAC system will far outweigh any additional project length.

KEYWORDS: documentation, validating, building services, commissioning, USA, laboratories, air quality, indoor, testing.