Tag: OOS

“`html Addressing Non-uniform Granule Size to Ensure Inspection Readiness In the world of pharmaceutical manufacturing, the quality of the granulation process is crucial to ensuring consistency in product performance, stability,…

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…