Tag: Quality Systems

Investigating Leakage Failures in EU/UK Distribution Qualification: A Comprehensive Approach In the competitive landscape of pharmaceutical manufacturing, ensuring product integrity throughout the distribution lifecycle is paramount. A common yet critical…

Assessing Canister Corrosion in MDI Assembly: Distinguishing Method Variability from True Product Failures Canister corrosion is a critical issue impacting the integrity and efficacy of Metered-Dose Inhalers (MDIs). This problem…

Investigating OOS in Particle Size Distribution Following a Change in Valve Supplier In the ever-evolving landscape of pharmaceutical manufacturing, maintaining consistent product quality is paramount. An Out of Specification (OOS)…

Assessing Particle Size Distribution OOS During Line Setup: A Practical Investigation Guide In the realm of pharmaceutical manufacturing, maintaining product quality and consistency is paramount. One common issue that emerges…

Investigation into Valve Malfunction during Stability Pull Investigations In pharmaceutical manufacturing, a valve malfunction during stability pull poses significant challenges, particularly regarding product quality and compliance. Such incidents can lead…

Understanding Canister Corrosion in MDI Assembly: A Comprehensive Investigation Approach Canister corrosion in metered-dose inhaler (MDI) assemblies can compromise product integrity, leading to deviations, out-of-specification (OOS) findings, and potential regulatory…

Addressing Out of Specification Issues in Particle Size Distribution During MDI Assembly Particle size distribution (PSD) is critical in the assembly of Metered Dose Inhalers (MDIs). Out of Specification (OOS)…

Investigating Leakage Failures During Method Transfer in Pharmaceutical Manufacturing Leakage failures during method transfer, particularly related to aerosol formulations, represent a significant challenge in pharmaceutical manufacturing. These failures can adversely…