Is it possible to qualify/validate identical equipment so I don’t have to perform three trials in each unit? If yes, how should I approach that effort?
[b][COLOR=“blue”]Many firms purchase identical equipment units for use in their processes, including such items as processing vessels, mills, tablet presses, autoclaves and lyophilizers. It is certainly possible to demonstrate that identical equipment operates in an identical manner. The qualification/validation effort should be designed to establish that the units perform in an identical fashion throughout the operational range. This can be accomplished by physical measurement of speed, internal temperature and the like, as well as by confirmation of product/process consistency through such aspects as content uniformity, F0 or other key criteria.
Data from identical equipment should give equivalent results when utilized for the same process, and that equivalence demonstrates their interchangeability. Once equivalence is established, the validation effort for the processes operated in the equipment can be greatly simplified. This approach is even appropriate for single equipment items. The goal in re-qualification/re-validation is to support that the equipment performs over time in a manner equivalent to the initial effort.
It is important to be realistic in setting the criteria for demonstration of equivalence. If the criteria are too restrictive, it is possible to conclude that a piece of equipment is non-equivalent to itself. The variation between identical items should be only slightly greater than the variation between repeated trials in a single equipment item. Substantial difference should be cause for concern. The FDA’s perspective on equivalence was defined in a warning letter sent to a firm claiming equivalence non-identical equipment[/color][/b]
This was one of the question that was asked during a Workshop recently.