OOS – Page 35 – Pharma.Tips

Exhaust clogging after batch size change – equipment vs process investigation

Investigating Exhaust Clogging Issues After a Batch Size Change in Pharmaceutical Manufacturing Equipment failures, such as exhaust clogging, often manifest during processes that have recently undergone changes—like adjustments in batch…

Over-wetting during coating during inspection – regulatory observation risk

Addressing Over-Wetting During Coating to Minimize Regulatory Inspection Risks In the realm of pharmaceutical manufacturing, the integrity of coating processes is pivotal. Over-wetting during coating not only jeopardizes product quality…

Pan speed fluctuation during inspection – CAPA ineffectiveness

Addressing Pan Speed Fluctuation During Inspection: A Comprehensive Guide The fluctuation of pan speed during production inspections can lead to significant hurdles in pharmaceutical manufacturing. When this critical parameter fails…

Tablet twinning after batch size change – regulatory observation risk

Addressing Tablet Twinning Risks After Changing Batch Sizes in Pharmaceutical Manufacturing In pharmaceutical manufacturing, the integrity of product quality can be compromised by machine performance, especially when batch sizes change.…

Pan speed fluctuation during film coating – equipment vs process investigation

Addressing Pan Speed Fluctuations in Film Coating: Practical Solutions for Equipment and Process Investigations In the highly regulated environment of pharmaceutical manufacturing, maintaining consistency in processes is critical. Among the…

Inlet air temperature drift during inspection – equipment vs process investigation

Addressing Inlet Air Temperature Drift During Equipment Inspection: An Effective Investigation Approach In the world of pharmaceutical manufacturing, maintaining precise inlet air temperature is critical, especially during equipment inspections. A…

RMG torque fluctuation during inspection readiness – CAPA and control strategy gap

Addressing Torque Fluctuation Issues in RMGs for Improved Inspection Readiness In the pharmaceutical manufacturing sector, unexpected fluctuations in the torque during the operation of a Rapid Mixer Granulator (RMG) can…

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

Addressing Insufficient End-Point Detection in Validation Processes In the pharmaceutical manufacturing landscape, inadequate end-point detection during validation can lead to significant challenges, ranging from compromised product quality to regulatory scrutiny.…

Non-uniform granule size during drying phase – CAPA and control strategy gap

Addressing Non-uniform Granule Size During the Drying Phase: Practical Solutions During the manufacturing of solid dosage forms, achieving uniform granule size is crucial for ensuring consistency in product performance. One…

Binder spray nozzle blockage during drying phase – process vs equipment root cause

Addressing Binder Spray Nozzle Blockage During the Drying Phase: Insights into Process and Equipment Failures Binder spray nozzle blockages during the drying phase can significantly disrupt pharmaceutical manufacturing processes, especially…

Over-wetting observed during inspection readiness – inspection risk analysis

Analyzing Over-wetting Issues in Granulation Equipment for Inspection Readiness Over-wetting is a significant concern in pharmaceutical manufacturing, particularly during the granulation process involving Fluid Bed Dryers (FBD) and Rapid Mix…

Inadequate end-point detection during validation – inspection risk analysis

Identifying and Addressing Inadequate End-Point Detection During Validation In the pharmaceutical manufacturing landscape, validation failures linked to inadequate end-point detection can escalate quickly into significant compliance issues, affecting product quality…