Boon Logic Resources
What Is an FDA Complete Response Letter (CRL)?
A Complete Response Letter (CRL) is an FDA communication issued when a New Drug Application (NDA) or Biologics License Application
What Is a Pre-Approval Inspection — and Why CMOs Are the Last Line
A Pre-Approval Inspection is the most consequential FDA visit any drug program will ever receive. It is the only inspection
Why Lyophilized Injectable Inspection Breaks Every Rule in Traditional Automated Vision
Lyophilized injectables are the fastest-growing segment of the injectable drug market. They are also the hardest products in the modern
The Gap in Pharma Visual Inspection Systems
Executive Summary The gap in visual inspection for difficult-to-inspect injectable products is widening as biologics and lyophilized injectables reshape pharmaceutical
Why Supervised Machine Learning Falls Short in Pharma Visual Inspection
Introduction This blog explores the differences between supervised and unsupervised machine learning, the ideal applications for each, and the challenges
Artificial Intelligence Applied to Pharmaceutical Visual Inspection
Introduction In pharmaceutical manufacturing, visual inspection is a critical quality control measure that has traditionally relied on human inspectors. However,