Design control is a meticulously structured process employed to oversee and regulate the design and development of pharmaceutical products, medical devices, and other regulated items, ensuring alignment with user needs and intended use, as well as compliance with regulatory mandates. It encompasses comprehensive planning, input gathering, output creation, verification, validation, change management, and transfer activities to guarantee the safety, effectiveness, and adherence to predetermined quality benchmarks of the products. Effective implementation of design control processes is paramount to ensuring the quality, safety, performance, and regulatory conformity of pharmaceutical products.
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