Tag: ICH

Investigating Disintegration Failures during Continuous Process Verification Reviews In pharmaceutical manufacturing, ensuring the integrity and efficacy of solid oral dosage forms, such as tablets and capsules, is crucial. A common…

Investigating Disintegration Failures Following Stability Pulls: Effective Troubleshooting Techniques Disintegration failures post-stability pull can pose significant challenges in pharmaceutical manufacturing, affecting product quality and regulatory compliance. This issue demands a…

Investigating Capsule Fill Weight Variation During CPV Review: Understanding Process Parameter Limits and Validation Impacts Capsule fill weight variation is a common issue observed in pharmaceutical manufacturing, particularly during the…

Investigating Friability Failures during High-Speed Tablet Runs in Pharma Manufacturing Friability failures during high-speed runs present a significant challenge in pharmaceutical manufacturing, particularly for solid oral dosage forms like tablets.…

Dissolution Issues During High-Speed Runs: Conducting a Root Cause Investigation with CAPA Framework In the highly regulated environment of pharmaceutical manufacturing, a dissolution failure during high-speed runs can significantly impact…

Addressing Capsule Fill Weight Variation Post-Maintenance: How to Meet FDA and EMA Documentation Standards In pharmaceutical manufacturing, the integrity of capsule fill weights is critical for compliance with both FDA…

Understanding Assay Drift In Stability Testing: Investigative Approaches To Prevent Repeat OOS Findings In the realm of pharmaceutical manufacturing, assay drift on stability can lead to unexpected out-of-specification (OOS) results,…

Investigating Disintegration Failure in Multi-Strength Campaigns: Effective Sampling Plan Fixes to Prevent Repeat OOS Events In the realm of pharmaceutical manufacturing, the integrity of dosage forms is paramount. Disintegration failure…

Root Cause Analysis of Tablet Capping Issues for FDA Inspection Readiness Tablet capping is a significant concern for pharmaceutical manufacturers, particularly during FDA inspections. If left unaddressed, these issues can…

Addressing Blend Segregation Challenges Following Scale-Up: Parameters and Validation Considerations Blend segregation can pose significant challenges during the scale-up of solid oral dosage forms in pharmaceutical manufacturing. The potential for…

GMP Investigation Steps for Content Uniformity OOS Following Stability Pull In pharmaceutical manufacturing, ensuring content uniformity is critical for both product quality and compliance. A post-stability pull that reveals an…

Addressing Capsule Fill Weight Variation for FDA Inspection Readiness: Troubleshooting Tooling, Granulation, and Lubrication In the pharmaceutical manufacturing landscape, variations in capsule fill weight can prompt significant regulatory scrutiny, particularly…