Cost-Effective Equipment Qualification

Reducing the qualification burden through some practical considerations and a pragmatic, and controlled approach

Equipment qualification has become a significant cost factor in the purchase, installation and start-up of equipment in both the Pharmaceutical and Medical Device Industries. For some manufacturers, equipment qualification now represents nearly 40% of capital acquisition costs. On a purchase of $ 2MM, the cost of qualification can approach $ 1MM. This is a significant financial burden to carry on top of the traditional amortization costs of the equipment.

In addition to these tangible costs, there are other, less concrete, costs associated with equipment qualification. The time spent qualifying the equipment adds to the actual expenditures by postponing the start-up of the equipment as well as delaying the moment when the cost savings begin. The lack of properly developed Standard Operating Procedure (SOP) is another factor that can delay the start-up of the equipment thereby generating additional soft costs.

When purchasing equipment, the Pharmaceutical or Medical Device manufacturer's goal is to begin production as soon as possible. An important factor in achieving this is to understand the difference between what must be done under the current regulations and what one may interpret the legislation to mean. It has been our experience that different Compliance Officers have different interpretations of the requirements.