Category: Blogs

When particulate matter is detected in sterile injectable products, manufacturers must take swift, structured steps to investigate and assess potential risks. This guide covers essential actions—from referencing particle libraries to conducting root cause investigations and risk assessments—to ensure product quality and patient safety.

Properly designed defect test sets are essential for qualifying inspectors in pharmaceutical visual inspection. This post explores the optimal size, defect percentage, and customization needed to ensure that test sets accurately reflect real-world conditions, enhancing inspector proficiency and product safety.

A defect library is a crucial quality control tool that enhances defect identification, classification, and management in pharmaceutical manufacturing. By providing a standardized reference, it improves inspection consistency, supports regulatory compliance, and drives continuous improvement, ultimately ensuring high product quality and patient safety.

An effective CAPA process for visual inspection issues is crucial for maintaining product quality and regulatory compliance. By avoiding common pitfalls like inadequate data analysis, superficial root cause identification, and poor documentation, you can create a CAPA process that resolves immediate issues and prevents future occurrences, strengthening your visual inspection program.

To ensure compliance with regulatory expectations and enhance the quality of injectable products, a robust visual inspection program must integrate supplier quality agreements, risk assessments, and continuous improvement measures. This blog outlines key steps, from establishing particulate matter controls with suppliers to refining inspection methodologies and training programs, to help maintain product safety and quality.