Regulatory Focus™ > News Articles > RA Manager: Establishing a New Material Review Board

RA Manager: Establishing a New Material Review Board

Posted 01 April 2008 | By

When making the transition from product development to commercialization, one consideration is the need for a material review board (MRB). This need becomes clear when the first major deviation or event occurs and quality assurance (QA) is left on its own to evaluate the data, determine the outcome of an investigation and communicate the final disposition of the product in question. When this occurs without a material review board in place, the rest of the organization sometimes accuses QA of failing batches without any technical discussion or communication with other departments. QA can then either accept the stigma of being thought of as a "silo" department or take action to correct the situation. In the author's experience, it is best to act, and the solution is to establish a material review board.

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