100% inspection does not mean 100% defect detection
There is a common misunderstanding that 100% visual inspection (VI) of biopharmaceutical products is, or should be, equivalent to 100% detection of defects. This misunderstanding is repeated across geographies and companies, and arises within companies and externally.
If you routinely work in VI, you will understand that the process is inherently probabilistic, meaning that despite all units of a product undergoing 100% VI, systematically identifying all defects is not guaranteed. Those who do not routinely work in VI but are required to ‘audit or review the inspection’ often misunderstand the probabilistic nature of inspection and propagate the issue of equating inspection with detection.
Our paper illustrates that the probabilistic nature of detection is well understood. It dispels the misunderstandings associated with VI through examples and highlights that the probabilistic nature of an inspection is recognized in multiple regulatory guidance documents.
Our paper will give you confidence in your existing VI capability and its capability to detect different types and presentations of defects. It will allow you to use risk management and remediation in your atypical event investigations. It also helps you understand regulatory requirements and market expectations.
This paper, which applies primarily to routine manufacture, addresses the probabilistic nature of VI and the factors that might influence inspection performance and reliability. It also addresses regulatory requirements and market expectations.
|100% inspection does not mean 100% defect detection January 2023.pdf|
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- Create Date 13th January 2023
- DOI https://doi.org/10.46220/2022FF002
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