Tag: MHRA

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…

Understanding Propellant–Formulation Incompatibility during Method Transfer: A Detailed Investigation Approach In the pharmaceutical manufacturing realm, particularly within aerosol formulations, issues with propellant–formulation incompatibility can arise during method transfers. These complications…

Addressing Leakage Failure during Method Transfer in Pharmaceutical Manufacturing In pharmaceutical manufacturing, maintaining the integrity of dosage forms is crucial, particularly during method transfers from development to production. One common…