The intent of this paper is to illustrate that the probabilistic nature of detection is well understood and it aims to dispel the misunderstandings associated with VI through illustrated examples and by highlighting that the probabilistic nature of inspection is recognized in multiple
regulatory guidance documents.
Visual inspection
Viewing related articles
Approaches to visible particulate control strategy
Oct 2022 | Benchmarking, Cell & Gene Therapy, Deliverable, Deliverables Report, Regulatory Strategy
A BioPhorum member survey aimed to gather initial industry benchmarking data and interest in defining an industry position on visible particulate control strategy for cell and gene therapies.
Test Download
Oct 2022 | Deliverable, Deliverables Report, Fill Finish, Publication, Visual Inspection
This member only paper explains how 100% inspection is not the same as 100% detection of defects, how VI is probabilistic in nature, how the probabilistic nature is noted is all major regulatory guidance, and explaining how probability of detection varies with a range of product and defect categories
100% misunderstanding
Oct 2022 | Deliverable, Deliverables Report, Fill Finish, Publication, Visual Inspection
This member only paper explains how 100% inspection is not the same as 100% detection of defects, how VI is probabilistic in nature, how the probabilistic nature is noted is all major regulatory guidance, and explaining how probability of detection varies with a range of product and defect categories
Visual inspection of drug product bag for Phase I/II CT program
Oct 2022 | Benchmarking, Cell & Gene Therapy, Commercialization, Deliverable, Deliverables Report
A BioPhorum member only survey, the goal of which is to understand what the current industry standard is for visual inspection of final drug product bag for Phase I/II autologous/allogeneic cell therapy programs.
Standardized methodology to support particle investigations and classification in biopharmaceutical parenteral products
Dec 2021 | Deliverables Report, Fill Finish, Publication, Visual Inspection
This paper provides a framework to support investigations related to atypical or frequently occurring particles observed during VI or related to field complaints – which require detailed and systematic assessment of risk to the quality of the batch. The proposal for a standardized risk investigation methodology outlined in this paper may support such risk assessments, where the total risk related to foreign particles is assessed by considering a variety of risk factors (type, frequency, etc.) and applying a failure mode and effects analysis (FMEA) tool to calculate a total risk-based score.
Technology for visual inspection benchmarking survey
Oct 2021 | Benchmarking, Fill Finish, Visual Inspection
A member only benchmark examining the technology trends in visual inspection.