Tag: root cause

Analyzing RMG Torque Fluctuations During Validation: A Comprehensive Inspection Risk Analysis In the world of pharmaceutical manufacturing, having a reliable and consistent granulation process is pivotal. One common issue that…

Inspection Risk Analysis of Over-Wetting During Wet Granulation Over-wetting during wet granulation is a critical issue that can compromise product quality and regulatory compliance in pharmaceutical manufacturing. The problem manifests…

Mitigating Over-Wetting Issues in the Drying Phase: A Practical Guide Over-wetting observed during the drying phase of pharmaceutical manufacturing poses significant risks to product quality, compliance, and overall operational efficiency.…

Addressing Granule Attrition Issues During the Drying Phase: Equipment vs Process Root Causes During the pharmaceutical manufacturing process, granule attrition can pose significant quality risks, particularly during the drying phase.…

Resolving Inconsistent FBD Drying Post-Scale-Up: An Inspection Readiness Approach In the pharmaceutical manufacturing sector, complications during scale-up processes can manifest as significant inconsistencies in fluid bed dryer (FBD) performance, particularly…

Addressing Over-Wetting in Granulation After Scale-Up: A Practical CAPA Framework In the pharmaceutical manufacturing realm, scaling up from lab to production can pose significant challenges, one of which is the…