Quality by Design and Risk Assessment for Radiopharmaceutical Manufacturing and Clinical Imaging

Abstract

IAEA), World Health Organization (WHO) and European Association of Nuclear Medicine (EANM). The attributes of the components in the quality system (QA/QC), including organization, staffing and personnel, facilities, instrumentation and equipment, operation procedure, radiopharmaceuticals, protocol and conduct of a study or a treatment, records and reports, and audit framework were further characterized. Assessments and comparisons of critical quality attributes (CQAs) for assuring accurate radioactive dosimetry calculation in the efficiency tracing of absolute activity measurement and patient-and technologistrelated risks for nuclear medicine imaging including Positron Emission Tomography (PET), Computed Tomography (CT), PET/CT, and Single Photon Emission Computed Tomography (SPECT) were identified. Quality system design based on the Requirements and Guidelines Quality policy and systemThe quality system by design for radiopharmaceuticals and clinical imaging techniques is aimed to maintain and improve the qualified service for the patients, fulfill the regulatory requirements, optimize the safety and efficacy for patient care, demonstrate a proper equipment operating condition, and obtain a reliable quantitative performance in both diagnostic and therapeutic nuclear medicine procedures [4,5]. The pursuit of excellence in quality system is not a single action over a short period, instead, it is achieved through the whole life cycle of instruments, analytical methods or education for example, from planning and procurement to decommissioning based on advanced technology [6]. Continuous quality improvement implies a commitment to continuously struggle to advance based on state-ofthe-art information and techniques developed by the nuclear medicine and metrology community at large [5].Implementation of a quality system must be in accordance with the quality police, i.e. the overall quality intentions and direction of an organization, as formally expressed by top management. And quality system includes the structure, responsibilities, and procedures for implementing quality management. An integrated infrastructure of quality policy and system design is demonstrated as in Figure 1, which is mainly developed from the European Standard EN 28402 proposed by Bergmann et al. [7]. The attributes of the components in the quality sub-system (QA/QC), e.g. organization, personnel, facilities, instrumentation, operation procedures, preparation of radiopharmaceuticals, protocol and conduct, records and reports, and audit or inspection, were further integrated and classified in this article.

An Overview of PET Radiopharmaceuticals in Clinical Use: Regulatory, Quality and Pharmacopeia Monographs of the United States and Europe

“…Even costly implementation and maintenance of quality system for a PET radiopharmaceutical manufacturing (or preparing) site [10,11], it is still thought to be cost-effective [12]. Moreover, it will be helpful for qualified patient care, regulatory requirements, optimization of safety and efficacy for patient care and a reliable quantitative performance in both diagnostic and therapeutic nuclear medicine procedures [13].…”