This chapter summarizes the evolution of quality control since the inception of PET imaging through today. It analyzes the industrial and regulatory trends that have contributed to the definition of requirements for quality control. This background frames the development of automated solutions for quality control that are discussed in this chapter in a sequence following gradual departure from conventional methods. Regulatory aspects for implementation of innovative quality control solutions are also analyzed with some recommendations for the end users. A discussion of relative advantages of different past and current approaches is followed by an outlook to future possibilities in context of expected future trends within the PET industry.

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Quality Control Automation Solutions for PET Drug Production

  • Arkadij Elizarov,
  • Joshua Ashton

摘要

This chapter summarizes the evolution of quality control since the inception of PET imaging through today. It analyzes the industrial and regulatory trends that have contributed to the definition of requirements for quality control. This background frames the development of automated solutions for quality control that are discussed in this chapter in a sequence following gradual departure from conventional methods. Regulatory aspects for implementation of innovative quality control solutions are also analyzed with some recommendations for the end users. A discussion of relative advantages of different past and current approaches is followed by an outlook to future possibilities in context of expected future trends within the PET industry.