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Inspectorates Share QRM Tools to Protect Quality from Downsizing

 
• By Bowman Cox

Quality risk management is touted as the key to preventing, or if needed, preparing for the brain drain that can affect drug quality when a plant loses key personnel due to staff cuts. PIC/S encourages drug makers to try the QRM tools its members use when inspecting plants.

Drug manufacturers should use quality risk management tools to prepare for the loss of expertise that comes with downsizing, Tor Graberg, head of Sweden’s pharmaceutical inspectorate, told the Parenteral Drug Association in April.

Too often, management doesn’t realize how self-inflicted brain drain affects drug quality until after the damage occurs, he told the quality systems interest group April 16 at PDA’s annual meeting...

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