Quality Systems – Page 255

Phase Separation after supplier change: sanitation, water, and EM checks

Investigation of Phase Separation Issues Following Supplier Change: Best Practices for Sanitation, Water, and Environmental Monitoring The pharmaceutical industry must ensure that all products meet stringent quality standards. A notable…

Canister Corrosion in MDI assembly: packaging integrity and transport risk assessment

Assessing Canister Corrosion in MDI Assembly: A Comprehensive Investigation Canister corrosion in Metered Dose Inhalers (MDIs) poses significant risks to product integrity and patient safety, resulting in out-of-specification (OOS) events…

Canister Corrosion after valve supplier change: device qualification and crimp validation controls

Addressing Canister Corrosion Following Valve Supplier Modification: Effective Device Qualification and Crimp Validation Controls In recent months, a significant increase in canister corrosion incidents has been observed in aerosol formulations…

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…

Tag: Quality Systems