There is a common misunderstanding that 100% visual inspection of biopharmaceutical products equates to 100% detection of defects. The 100% visual inspection the process is inherently probabilistic, meaning that identifying all defects is not guaranteed. The intent of this paper is to illustrate that the probabilistic nature of detection is well understood and aims, through examples, to dispel the misunderstandings associated with visual inspection. The authors hope this paper clarifies why 100% visual inspection ≠ 100% defect detection, and that the probabilistic nature is based in science and laid out as such in regulatory guidance.
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