'MQs' touted for handling some legacy computers.

LAS VEGAS - Jerilynn Carroll, a principal consultant at Commissioning Agents told the annual ISPE meeting Oct. 30 what she described as a new approach to qualifying "indirect impact" legacy systems: Modified Qualification (MQ).

For this re-qualification work, she advocated developing a validation master plan (VMP) as a "living" document that provides overriding authority for all validation activities and that defines all the requirements and activities necessary to meet GMPs. "Computer systems validation," she emphasized, "is not a separate task."

In addition to the normal choices of validation activities available (commissioning, design, installation, or operational qualification, prospective or retrospective), "I am proposing to add Modified Qualification," she said, "a new concept to be used sometimes for legacy systems."

"MQ is a combined installation and operational qualification effort," she explained. "Critical parameters are identified using historic data (batch records, etc.), and the performance of the system is assessed against the parameters."

"Deciding which validation elements to use depends," she said, "on the impact and tenure of the system."

She recommended first of all classifying equipment as either having a direct, indirect or no impact on the system. Equipment with a direct impact directly influences product quality, e.g., equipment that determines dose, sterility, ability to maintain critical parameters such as temperatures, makes quality decisions like vision systems, or labels products.

Equipment or systems with an indirect impact support direct impact equipment. Since it may affect the performance of the direct impact equipment, the interface needs to be carefully assessed. "For example," Carroll explained, "is there an interlock that prevents the system from operating if the compressed air supply is not at the correct pressure?" Plant steam and condensate, chilled water, and instrument air fall into this category.

Office HVAC, and waste systems are examples of equipment that have no impact.

Validation requirements are determined by the equipment or system's impact on the process. Equipment with no impact requires only commissioning. Equipment with an indirect impact requires limited validation at a medium cost in money and time. Direct impact equipment demands full validation with consequent increased cost and time.

"There must be full validation for all new systems and for direct impact legacy systems," Carroll said. A new system with a direct or indirect impact will require DQ, commissioning, IQ, OQ, prospective PQ, and supporting documentation. A legacy system with a direct impact will differ only in requiring retrospective instead of prospective PQ. But a legacy system with an indirect impact will require only Modified Qualification.

"This," Carroll explained, "is a less elaborate, streamlined approach for indirect legacy systems." It concentrates on the critical parameters, confirms the drawings, ensures that system documentation is complete, tests performance, and results in a summary that will fully inform regulators.

Asked if the MQ approach has been challenged by FDA, a cautious answer was provided by Thomas Arista, FDA Investigator/Expert, Biotechnology, who was also on the platform. "The first thing firms have to do is to defend the term. After that, O.K."