EMA – Page 190 – Pharma.Tips

Particle Size Distribution Oos at stability pull: packaging integrity and transport risk assessment

Addressing Deviations in Particle Size Distribution During Stability Evaluation In pharmaceutical manufacturing, adherence to quality standards is critical, particularly when it comes to particle size distribution (PSD) in aerosol formulations.…

Crimp Diameter Variability during EU/UK distribution qualification: packaging integrity and transport risk assessment

Assessing Crimp Diameter Variability in EU/UK Distribution Qualification: A Comprehensive Investigation In pharmaceutical manufacturing, ensuring the integrity of packaging is crucial for maintaining product quality during distribution. A notable concern…

API XRPD mismatch during process validation campaign: data integrity and chromatographic audit trail review steps

Addressing API XRPD Mismatch During Process Validation Campaigns: A Comprehensive Investigation Guide In the complex environment of pharmaceutical manufacturing, an XRPD (X-ray Powder Diffraction) mismatch noted during a process validation…

Hold Time Bioburden Rise after supplier change: sanitation, water, and EM checks

Understanding Hold Time Bioburden Increases Following Supplier Changes In pharmaceutical manufacturing, particularly for otic dosage forms, the control of bioburden during hold times is critical to product integrity and compliance.…

Pressure Loss in MDI assembly: device qualification and crimp validation controls

Understanding Pressure Loss in MDI Assembly: Investigative Strategies and Controls Pressure loss in Metered Dose Inhalers (MDIs) is a critical concern during pharmaceutical manufacturing that can impact both the efficacy…

Net Content Failure after valve supplier change: device qualification and crimp validation controls

Investigation of Net Content Failure Following a Valve Supplier Change in Pharmaceutical Manufacturing Pharmaceutical professionals frequently encounter challenges that arise from variations in components or processes. One such problematic scenario…

Propellant–Formulation Incompatibility after valve supplier change: packaging integrity and transport risk assessment

Addressing Propellant–Formulation Incompatibility Following a Valve Supplier Change In the complex landscape of pharmaceutical manufacturing, the introduction of a new component can lead to unforeseen complications, particularly when it affects…

API photostability failure during CPV trending review: regulatory impact assessment and change control remediation plan

Assessing Regulatory Impact and Change Control Following API Photostability Failures in CPV Trends In pharmaceutical manufacturing, photostability studies are vital for ensuring the quality and stability of Active Pharmaceutical Ingredients…

Ph Drift after supplier change: GMP documentation for FDA/EMA/MHRA review

Investigation of pH Drift Following a Supplier Change in Otic Dosage Forms In recent months, several quality control (QC) analysts have reported shifts in pH levels in otic dosage forms…

Leakage Failure during line setup: packaging integrity and transport risk assessment

Analyzing Leakage Failures during Line Setup: A Comprehensive Investigation Guide In pharmaceutical manufacturing, particularly in the production of aerosol formulations, maintaining packaging integrity is crucial. A leakage failure during line…

E&L Failure during line setup: GMP investigation and CAPA evidence pack

GMP Investigation of E&L Failures during Line Setup and Effective CAPA Implementation During the setup of aerosol manufacturing lines, Extractables and Leachables (E&L) failures can present significant risks to product…

API nitrosamine risk exceedance during routine release testing: data integrity and chromatographic audit trail review steps

Investigating API Nitrosamine Risk Exceedance During Routine Release Testing: Audit Steps and Solutions API nitrosamine risk exceedance has emerged as a critical concern for pharmaceutical manufacturers, particularly during routine release…