Tag: root cause

Understanding and Addressing Dissolution Failures During Stability Pulls Dissolution failure during stability pulls can present a significant challenge in pharmaceutical manufacturing, particularly in tablets. When faced with an out-of-specification (OOS)…

Investigation of Tablet Capping During Stability Pull: Evaluating Process and Formulation When conducting stability pulls in pharmaceutical manufacturing, it’s critical to ensure product integrity. An alarming observation, such as tablet…

Analyzing Friability Failures After Scale-Up: A Structured Investigation Approach Manufacturers in the pharmaceutical industry frequently face challenges, particularly during scale-up processes. One common issue is friability failure, which can lead…

Understanding Disintegration Time Failures During Campaign Changeover and Their Regulatory Implications Manufacturing defects, particularly in the context of disintegration time during campaign changeovers, pose significant challenges to pharmaceutical manufacturers. Such…

Investigating Content Uniformity OOS During Campaign Changeover in Pharmaceutical Manufacturing Pharmaceutical manufacturing processes are highly regulated and require an unwavering focus on quality. One common problem that arises is the…

Assessing Friability Failures During Stability Pull: A Comprehensive Investigation Approach In the dynamic landscape of pharmaceutical manufacturing, friability failures during stability pulls can lead to significant regulatory scrutiny and production…

Addressing Black Specks Detected During Campaign Changeover: A Comprehensive Investigation Approach Manufacturers in the pharmaceutical industry periodically encounter unexpected results that can lead to regulatory scrutiny and operational disruptions. One…

Assessing Hardness Drift Following Tooling Changes: A Comprehensive Investigation Manufacturing defects in pharmaceuticals can lead to significant quality issues, regulatory challenges, and product recalls. One common problem encountered during tablet…

Addressing Lamination Defects in Tablets During Stability Testing: A Comprehensive Investigation Approach Tablet lamination defects during stability pulls represent significant challenges in pharmaceutical manufacturing, which can lead to Out of…

Analyzing Hardness Drift During Campaign Changeover: A Root Cause Investigation In pharmaceutical manufacturing, ensuring consistent product quality is paramount. Hardness drift during campaign changeover, a common but critical issue, can…

Investigating Tablet Capping Issues Following Tooling Changes in Manufacturing The emergence of tablet capping during production can signal serious quality concerns, especially after tooling changes. Such events not only jeopardize…

Investigating Friability Failures Post Scale-Up: A Process vs. Formulation Approach Friability failures can pose significant challenges in pharmaceutical manufacturing, particularly during the scale-up phase. Understanding the underlying causes and implementing…