OOS – Page 38 – Pharma.Tips

RMG torque fluctuation during validation – CAPA and control strategy gap

Addressing Torque Fluctuation in RMG During Equipment Validation: A Problem-Solution Guide The occurrence of torque fluctuations in a Rapid Mixer Granulator (RMG) during the validation phase is a critical concern…

Granule attrition issue during inspection readiness – CAPA and control strategy gap

Addressing Granule Attrition During Inspection Readiness: A Practical Guide to CAPA and Control Strategies Granule attrition is a critical issue often identified during inspection readiness assessments in pharmaceutical manufacturing. This…

Inadequate end-point detection during drying phase – process vs equipment root cause

Addressing Inadequate End-Point Detection in the Drying Phase of Pharmaceutical Manufacturing Inadequate end-point detection during the drying phase of pharmaceutical production can lead to significant inefficiencies, compromised product quality, and…

Over-wetting observed after scale-up – inspection risk analysis

Assessing the Risk of Over-wetting After Scale-Up in Pharmaceutical Manufacturing In pharmaceutical manufacturing, particularly during scale-up of granulation processes, the phenomenon of over-wetting can have serious implications for product quality…

Non-uniform granule size during wet granulation – inspection risk analysis

Addressing Non-uniform Granule Size During Wet Granulation: An Inspection Risk Analysis In pharmaceutical manufacturing, achieving a uniform granule size during the wet granulation process is critical to ensure the efficacy…

Granule attrition issue after scale-up – process vs equipment root cause

Addressing Granule Attrition Challenges Post Scale-Up: A Practical Approach In the pharmaceutical manufacturing landscape, the transition from small-scale to large-scale production often uncovers various challenges, notably granule attrition. This issue…

Inadequate end-point detection during inspection readiness – CAPA and control strategy gap

“`html Addressing Insufficient End-Point Detection for Inspection Readiness: Gaps in CAPA and Control Strategy In pharmaceutical manufacturing, a consistent and reliable end-point detection mechanism is crucial for ensuring quality and…

Granule attrition issue during drying phase – inspection risk analysis

Managing Granule Attrition Issues During the Drying Phase: An Effective Workflow Granule attrition during the drying phase is a critical issue that can lead to non-compliance, increased rejection rates, and…

Binder spray nozzle blockage after scale-up – inspection risk analysis

Addressing Binder Spray Nozzle Blockage Post Scale-Up: An Inspection Risk Analysis Binder spray nozzle blockage after scale-up is a prevalent issue in pharmaceutical manufacturing that can lead to significant production…

Over-wetting observed during validation – process vs equipment root cause

Addressing Over-wetting Issues During Validation: Equipment Versus Process Root Causes Over-wetting during validation, especially in granulation processes, can signify underlying equipment or process failures. This absorption problem not only undermines…

Over-wetting observed during validation – inspection risk analysis

Analyzing Over-Wetting Issues During Validation: Strategies for Compliance and Quality Assurance Over-wetting during equipment validation is a critical failure signal that can jeopardize product quality and lead to significant compliance…

Binder spray nozzle blockage during drying phase – CAPA and control strategy gap

Addressing Blockage Issues in Binder Spray Nozzles During the Drying Phase The manufacturing process in pharmaceutical facilities is complex, and even minor equipment failures can lead to significant disruptions. One…