Tag: Quality Systems

Assessing Drop Test Failures During EU/UK Distribution Qualification: Navigating Method Variability and True Product Failures In the pharmaceutical manufacturing landscape, ensuring product integrity and compliance during distribution qualification is critical.…

Assessing Crimp Diameter Variability Following a Change in Valve Supplier In the highly regulated landscape of pharmaceutical manufacturing, variability in critical quality attributes (CQAs) can lead to significant compliance challenges.…

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.…

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…

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…

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…

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…