FDA – Page 278 – Pharma.Tips

E&L Failure during line setup: GMP investigation and CAPA evidence pack

GMP Investigation of E&L Failures during Line Setup and Effective CAPA Implementation During the setup of aerosol manufacturing lines, Extractables and Leachables (E&L) failures can present significant risks to product…

API nitrosamine risk exceedance during routine release testing: data integrity and chromatographic audit trail review steps

Investigating API Nitrosamine Risk Exceedance During Routine Release Testing: Audit Steps and Solutions API nitrosamine risk exceedance has emerged as a critical concern for pharmaceutical manufacturers, particularly during routine release…

Assay Oos during inspection readiness: packaging integrity and stability justification

Investigating Assay Out-of-Specification Events During Inspection Readiness As pharmaceutical professionals, we understand the criticality of maintaining quality and compliance during inspection readiness, particularly regarding assay out-of-specification (OOS) events. Such deviations…

Valve Malfunction during EU/UK distribution qualification: method variability vs true product failure assessment

Assessing Valve Malfunction during EU/UK Distribution Qualification: Distinguishing Method Variability from True Product Failure In the pharmaceutical manufacturing landscape, valve functionality plays a critical role in the effective delivery of…

Spray Pattern Failure in aerosol filling: GMP investigation and CAPA evidence pack

Investigating Spray Pattern Issues in Aerosol Filling: GMP Challenges and CAPA Measures The integrity of aerosol products is a critical aspect of pharmaceutical manufacturing that directly impacts product performance and…

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…