Deviation – Page 158

Crimp Diameter Variability in aerosol filling: method variability vs true product failure assessment

Understanding Crimp Diameter Variability in Aerosol Filling: Assessment of Method Variability and Actual Product Failures In pharmaceutical manufacturing, crimp diameter variability during aerosol filling poses significant challenges. These variabilities can…

API hygroscopicity-driven degradation during routine release testing: data integrity and chromatographic audit trail review steps

Addressing Degradation Issues from API Hygroscopicity During Routine Release Testing In the pharmaceutical industry, the stability of Active Pharmaceutical Ingredients (APIs) is critical to ensuring product efficacy and safety. One…

Microbial Limits Failure in ear drop manufacturing: sanitation, water, and EM checks

Exploring Microbial Limits Failures in Ear Drop Manufacturing: Strategies for Investigation and Control In the pharmaceutical manufacturing landscape, microbial limits failures pose significant challenges, particularly in the production of sterile…

Propellant–Formulation Incompatibility in MDI assembly: FDA/MHRA inspection-ready documentation

Understanding and Investigating Propellant–Formulation Incompatibility in MDI Assembly In the pharmaceutical manufacturing sector, particularly in the assembly of Metered Dose Inhalers (MDIs), propellant–formulation incompatibility can pose significant risks to product…

Canister Corrosion at stability pull: packaging integrity and transport risk assessment

Assessing Canister Corrosion During Stability Pulls: A Comprehensive Investigation Framework In the pharmaceutical manufacturing landscape, canister corrosion during stability pulls represents a critical risk factor for aerosol formulations. This phenomenon…

API particle size distribution failure after re-crystallization parameter adjustment: how to justify reprocessing vs rejection to FDA/EMA inspectors

Understanding API Particle Size Distribution Failures Post Re-Crystallization Parameter Adjustments In the realm of pharmaceutical manufacturing, maintaining the proper particle size distribution of active pharmaceutical ingredients (APIs) is crucial for…

Assay Oos after supplier change: sanitation, water, and EM checks

Investigation of Assay OOS Trends Following a Supplier Change In pharmaceutical manufacturing, changes in suppliers can introduce variability leading to Out-of-Specification (OOS) results. Addressing these challenges is critical, particularly in…

Propellant–Formulation Incompatibility during method transfer: packaging integrity and transport risk assessment

Assessing Propellant–Formulation Incompatibility during Method Transfer: Ensuring Packaging Integrity and Transport Risk In the dynamic landscape of pharmaceutical manufacturing, particularly with aerosol formulations, method transfers can present numerous challenges, notably…

Propellant–Formulation Incompatibility in aerosol filling: method variability vs true product failure assessment

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…

Net Content Failure after valve supplier change: packaging integrity and transport risk assessment

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…

API heavy metals / elemental impurities OOS during FDA inspection readiness: risk-based approach to prevent repeat OOS across future API batches

Managing OOS for Heavy Metals in API: A Risk-Based Investigation Framework As pharmaceutical manufacturers navigate the complexities of regulatory compliance, one critical aspect has come to the forefront: the Out…

Pet Failure in otic suspension filling: packaging integrity and stability justification

Investigating Pet Failures in Otic Suspension Filling: Ensuring Packaging Integrity and Stability In the pharmaceutical manufacturing sector, particularly within otic dosage forms, maintaining the integrity and stability of products during…