Tag: Quality Systems

Assessing Propellant and Formulation Incompatibility in Aerosol Filling: A Methodical Approach to Problem Solving In the realm of aerosol medication delivery, compatibility between the propellant and the formulation is critical…

Investigating Net Content Failures Following a Change in Valve Suppliers Pharmaceutical manufacturers often face regulatory scrutiny when deviations in product quality arise. One critical issue is net content failure, especially…

Addressing Crimp Diameter Variability in MDI Assembly: Your Guide to Effective Investigation Crimp diameter variability in Metered Dose Inhaler (MDI) assembly can lead to serious compliance issues and quality concerns…

Managing Drop Test Failures Following a Valve Supplier Change In the dynamic world of pharmaceutical manufacturing, change is a constant theme. However, changes such as a supplier switch, especially for…

Addressing Propellant–Formulation Incompatibility After Valve Supplier Change: A Focused Investigation Approach The pharmaceutical industry is witnessing increased complexity in formulation requirements and device compatibility. A significant issue arises when there…

Delivered Dose OOS in Aerosol Filling: Evaluating Method Variability vs. True Product Failure The occurrence of Out of Specification (OOS) results in aerosol filling processes presents significant challenges for pharmaceutical…

Addressing Spray Pattern Failures in the EU/UK Distribution Qualification of Aerosols In pharmaceutical manufacturing, ensuring the integrity of aerosol products during distribution qualifications is crucial. A recent incident involving a…