Quality by Design (QbD) is a concept based on the premise that quality should be planned into every process/product from the very start. This has been adopted by enforcement agencies globally and, as a result, has become a key approach to pharmaceutical quality. By selecting sterile personal protection equipment (PPE) manufactured using QbD principles, quality and sterility assurance managers can promote more efficient gowning and gloving techniques and minimise the risk of infection in pharmaceutical cleanrooms and pharmacies carrying out aseptic manipulation.
Robust drug handling, patient outcome and the health and safety of technicians and clinicians all rely on the creation and maintenance of an aseptic environment. Studies also demonstrate that comfort is an extremely important aspect of work performance, improved by clothing that helps maintain consistent body temperature.1 Ultimately, by reducing risk of infection and introducing PPE that simplifies the aseptic gowning process, quality and sterility assurance managers can improve productivity, help avoid costly errors and safeguard patients’ lives.
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