Knowledge Hub
Technical Resources & Publications
Access our published technical guides, regulatory references, and industry insights on visual inspection best practices for pharmaceutical manufacturing.
Publications
Templates, Tools & Technical Guides
Original implementation tools and in-depth publications for pharmaceutical visual inspection teams.
Manual Visual Inspection Program Starter Kit
An original SOP starter framework plus editable station, batch-record, defect-library, qualification, and reject-trending tools.
Visual Inspector Qualification Toolkit
Build a controlled qualification system with an editable protocol, challenge-set inventory, trial record, performance analysis, remediation workflow, and requalification planner.
New evidence hub · Test-set governance
Visual Inspection Test-Set Lifecycle Management
A source-linked framework for intended use, representativeness, bracketing, maintenance, requalification, replacement, and retirement across manual, SAVI, and AVI challenge sets.
Read the lifecycle guideComprehensive Guide for Transitioning from Manual to Semi-Automated Visual Inspection (SAVI)
This guide provides a structured, regulatory-aligned framework for pharmaceutical manufacturers transitioning from manual visual inspection to semi-automated systems. It covers risk assessment methodologies, equipment qualification protocols, operator training requirements, and validation strategies — all aligned with FDA Draft Guidance (2021), EU GMP Annex 1 (2022), USP <1790>, and PDA Technical Reports.
Developing Risk-Based Reject Limits for Automated Visual Inspection (AVI) Systems
A framework for developing and monitoring risk-based reject limits for AVI systems. It addresses the balance between detection sensitivity and false rejects using site-defined criteria, process knowledge, statistical analysis, and applicable FDA, EU GMP, and ICH Q9/Q10 sources.
Articles
Industry Insights & Analysis
Source-linked articles on visual inspection questions, regulatory updates, program design, and inspection science from YB Inspection.
Regulatory Framework
Key Regulatory References
These primary and consensus sources frame many of the technical questions discussed on this site. Applicability, source status, and site-specific requirements must be assessed for each product and market.
FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates
Addresses the development and implementation of a holistic, risk-based approach to visible particulate control.
USP <790> Visible Particulates in Injections
Establishes that injectable products must be essentially free of visible particulates.
USP <1790> Visual Inspection of Injections
Provides guidance on inspection methodology, inspector qualification, test sets, and Knapp studies.
EU GMP Annex 1: Manufacture of Sterile Medicinal Products
Sections 8.30-8.33 address AVI performance challenges, defect classification, and trending requirements.
21 CFR Part 211: Current Good Manufacturing Practice
Sections 211.68, 211.100, 211.110, and 211.134 are relevant to automated equipment, procedures, in-process controls, and examination of packaged products.
Stay Informed on Visual Inspection
We regularly publish new technical articles and industry insights on visual inspection topics including probability of detection studies, particle identification methodologies, and emerging regulatory trends.