Tag: EMA

Root Cause Analysis for Content Uniformity OOS During CPV Review In pharmaceutical manufacturing, content uniformity is a critical quality attribute, especially during commercial product verification (CPV) reviews. An Out of…

Steps to Investigate Tablet Lamination Issues Post-Maintenance in GMP Environment Pharmaceutical manufacturing is a highly regulated area, with small deviations potentially leading to significant compliance issues or product failures. One…

Investigating Sticking and Picking Issues Following an Excipient Change Sticking and picking are common challenges encountered in pharmaceutical manufacturing, particularly after an excipient change. These issues can lead to significant…

Addressing the Challenges of Sticking and Picking During Compression: A Structured Approach to OOS Investigation Sticking and picking during tablet compression remains a persistent challenge in pharmaceutical manufacturing, often leading…

Troubleshooting Friability Failures During Technical Transfer: Insights on Tooling, Granulation, and Lubrication In the realm of pharmaceutical manufacturing, friability failures during technical transfer can pose significant challenges. When tablet formulations…

Addressing Friability Failures during CPV Review: Troubleshooting Tooling, Granulation, and Lubrication Issues Friability failure during a Continuous Process Verification (CPV) review can significantly impact batch quality and regulatory compliance in…

Steps for Investigating Disintegration Failure Post Scale-Up in Pharmaceutical Manufacturing Disintegration failures following scale-up present critical challenges for pharmaceutical manufacturers. Such failures often lead to out-of-specification (OOS) test results, delays…

Understanding Tablet Lamination Challenges Post Scale-Up: A Guide for Compliance and Investigation In the pharmaceutical manufacturing space, tablet lamination can emerge as a significant issue following the scale-up phase. This…

Addressing Disintegration Failures for FDA Inspection Readiness: Effective Sampling Plans to Prevent OOS Disintegration testing is a critical quality control measure for oral solid dosage forms, such as tablets and…

Addressing Friability Failures Observed After Stability Pulls: An In-Depth Investigation In pharmaceutical manufacturing, the stability of solid oral dosage forms, such as tablets and capsules, is critical for ensuring product…

Analyzing Capsule Fill Weight Variation Following Stability Testing: Ensuring Compliance with Regulatory Expectations The pharmaceutical industry frequently encounters challenges during regulatory compliance, especially concerning stability studies that impact capsule fill…

Addressing Tablet Capping Issues Following Scale-Up: A Comprehensive Investigation Framework Tablet capping is a significant manufacturing concern that can arise during the scale-up of solid oral dosage forms. This article…