Facilitating quality by design through patient-centric specifications

Specifications are a part of an integrated vaccine control strategy. The current practice of setting acceptance criteria based on manufacturing variability has contributed to disparities in global specifications and thereby global quality. Instead, acceptance criteria should be based on assurance of patient requirements, both safety and efficacy, throughout a product’s shelf life. Such limits might be viewed as the CMC definition of quality, and a necessary component in the implementation of quality by design. Test limits, or patient-centric specifications, can be derived from patient requirements and used to guide formulation, process and analytical development, and lifecycle management, using scientific and risk-based studies aimed at minimizing patient and manufacturing risks. Clinical studies using dose-ranging and with modified vaccines have been proposed to justify patient requirements, while preclinical and in vitro technologies can be used to further support these efforts. While patient-centric specifications are determined to manage quality, manufacturing consistency can be achieved without impacting quality to patients.

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