Quality Systems – Page 239

API packaging moisture ingress issue after raw material supplier change: risk-based approach to prevent repeat OOS across future API batches

“`html Addressing Moisture Ingress Issues in API Packaging Following a Supplier Change In recent weeks, several manufacturing plants have reported out-of-specification (OOS) results related to moisture ingress in API packaging…

Pet Failure in ear drop manufacturing: investigation steps with CAPA evidence

Addressing Pet Failure in Ear Drop Manufacturing: A Comprehensive Investigation Approach Ear drop formulations are critical dosage forms, especially in veterinary applications. The success of these products hinges not only…

Drop Test Failure during EU/UK distribution qualification: device qualification and crimp validation controls

Addressing Drop Test Failures During EU/UK Distribution Qualifications In the high-stakes world of pharmaceutical manufacturing, ensuring the integrity of aerosol devices during distribution is pivotal. An alarming trend noted is…

Drop Test Failure after valve supplier change: packaging integrity and transport risk assessment

Assessing Drop Test Failures Following a Change in Valve Supplier: A Comprehensive Investigation In the highly regulated world of pharmaceutical manufacturing, deviations and failures can pose serious risks to product…

E&L Failure during EU/UK distribution qualification: GMP investigation and CAPA evidence pack

GMP Investigation and CAPA Evidence Pack for E&L Failure during EU/UK Distribution Qualification Effective investigation of Extractables and Leachables (E&L) failures during EU/UK distribution qualification is critical in pharmaceutical manufacturing.…

API co-crystal / salt form inconsistency after raw material supplier change: root cause analysis (process vs lab) with CAPA effectiveness checks

Analyzing API Co-Crystal/Salt Form Inconsistency After Changes in Raw Material Suppliers In recent times, pharmaceutical manufacturers have encountered significant challenges related to the inconsistency of API co-crystals or salt forms…

Phase Separation in otic suspension filling: GMP documentation for FDA/EMA/MHRA review

Addressing Phase Separation in Otic Suspension Filling: A GMP Investigation Guide Phase separation is a critical issue that can jeopardize the integrity of otic suspension formulations during the filling process.…

Spray Pattern Failure at stability pull: method variability vs true product failure assessment

Analyzing Spray Pattern Failures During Stability Pull: A Comprehensive Investigation Approach In the realm of pharmaceutical manufacturing, particularly concerning aerosol formulations, the integrity of the spray pattern is crucial for…

Canister Corrosion during line setup: packaging integrity and transport risk assessment

Addressing Canister Corrosion during Line Setup: A Comprehensive Investigation Guide Canister corrosion during line setup can pose significant risks to packaging integrity and product safety in pharmaceutical manufacturing. As the…

Pet Failure after supplier change: manufacturing vs lab root cause decision tree

Analyzing Pet Failure After Supplier Change: Manufacturing vs Lab Root Cause Decision Tree In the pharmaceutical industry, changes in suppliers can often lead to unexpected failures in product quality, such…

Valve Malfunction after valve supplier change: FDA/MHRA inspection-ready documentation

Investigating Valve Malfunction Following Supplier Change in Pharmaceutical Manufacturing In the realm of pharmaceutical manufacturing, changes in suppliers for critical components like valves can inadvertently lead to operational challenges, including…

Spray Pattern Failure in aerosol filling: packaging integrity and transport risk assessment

Investigation of Spray Pattern Deficiencies in Aerosol Filling: A Risk-Based Approach The integrity of aerosol filling processes is crucial for ensuring product quality and consistency in the pharmaceutical industry. A…