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Validation processes and the U.S. Food and Drug Administration

Serving the highly regulated pharmaceutical industry, what challenges did Contract Packaging Resources face in its acquisition of the new blister-thermoforming machine?
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Ed McGinnis, director of quality assurance, points out that CPR is registered with the FDA, the DEA, the Department of Agriculture, and the state of North Carolina. Compliance with these agency’s regulations is of paramount importance to the company’s success. All products are manufactured according to the current Good Manufacturing Practices. As Wade points out, “Validation of our equipment and process was an absolute necessity.”

CPR developed internal protocols with the assistance of Micron PharmaWorks to perform installation qualification [IQ], operational qualification [OQ], and process qualification [PQ] for the machine. These included validating the four separate components of the process: the color vision system, the printer, pinhole detector, and the basic thermoformer/cold former. Execution of these protocols was designed to assure that each component manufacturer achieved the requirements placed upon them and that CPR successfully installed and operated the equipment within customer/product specifications. The process was challenged in a variety of ways to assure that specifications were met and the limits of CPR’s operational capabilities determined.

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