Knowledge Hub
Technical Resources & Publications
Access our published technical guides, regulatory references, and industry insights on visual inspection best practices for pharmaceutical manufacturing.
Publications
Our Technical Guides
In-depth publications authored by our team covering critical topics in pharmaceutical visual inspection.
Comprehensive 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equipment qualification protocols, operator training requirements, and validation strategies — all aligned with FDA Draft Guidance (2021), EU GMP Annex 1 (2022), USP 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.
Establishing Compliant, Risk-Based Reject Limits for Automated Visual Inspection (AVI) Systems
A detailed framework for developing statistically sound, risk-based reject limits for AVI systems. This publication addresses the critical challenge of balancing sensitivity (detecting true defects) against specificity (minimizing false rejects) while maintaining compliance with FDA, EU GMP, and ICH Q9/Q10 guidelines. Includes practical methodologies for statistical analysis and ongoing monitoring.
Regulatory Framework
Key Regulatory References
Our products and services are designed to meet the requirements established by the following regulatory standards and guidelines.
FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates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 establish requirements for equipment qualification and inspection.
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.