MHRA – Page 181 – Pharma.Tips

Fill Volume Variability during inspection readiness: manufacturing vs lab root cause decision tree

Analyzing Fill Volume Variability: A Comprehensive Investigation for Manufacturing and Lab Settings Fill volume variability can pose significant challenges during inspection readiness, impacting both manufacturing processes and laboratory assessments. Whether…

Canister Corrosion in MDI assembly: method variability vs true product failure assessment

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…

Particle Size Distribution Oos after valve supplier change: GMP investigation and CAPA evidence pack

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)…

Pet Failure during method transfer: sanitation, water, and EM checks

Addressing Pet Failure During Method Transfer: Sanitation, Water, and Environmental Monitoring Checks In pharmaceutical manufacturing, method transfer is crucial for ensuring that processes maintain quality standards across different locations or…

Particle Size Distribution Oos during line setup: packaging integrity and transport risk assessment

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…

Valve Malfunction at stability pull: device qualification and crimp validation controls

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…

Canister Corrosion in MDI assembly: device qualification and crimp validation controls

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…

Preservative Miscalculation during inspection readiness: investigation steps with CAPA evidence

Steps for Investigating Preservative Miscalculation During Inspection Readiness In the realm of pharmaceutical manufacturing, particularly within the framework of otic dosage forms, ensuring the accuracy of preservative calculations is paramount…

Particle Size Distribution Oos in MDI assembly: device qualification and crimp validation controls

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)…

Leakage Failure during method transfer: device qualification and crimp validation controls

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…

Microbial Limits Failure during method transfer: GMP documentation for FDA/EMA/MHRA review

Addressing Microbial Limits Failures During Method Transfer in Pharmaceutical Manufacturing In the pharmaceutical industry, microbial limits testing is a critical component of ensuring product safety and quality. A microbial limits…

Propellant–Formulation Incompatibility during method transfer: device qualification and crimp validation controls

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…