Quality Systems – Page 253

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…

Crimp Diameter Variability in MDI assembly: FDA/MHRA inspection-ready documentation

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…

Drop Test Failure after valve supplier change: FDA/MHRA inspection-ready documentation

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…

API microbial limit failure during routine release testing: root cause analysis (process vs lab) with CAPA effectiveness checks

Root Cause Analysis of Microbial Limit Failures in API Release Testing In pharmaceutical manufacturing, the detection of microbial limit failures during routine release testing of active pharmaceutical ingredients (APIs) can…

Leakage Complaint during method transfer: investigation steps with CAPA evidence

Investigating Leakage Complaints during Method Transfer: Key Steps and CAPA Evidence In the landscape of pharmaceutical manufacturing, complaints regarding leakage during method transfer can present significant operational challenges. Such leakage…

Propellant–Formulation Incompatibility after valve supplier change: device qualification and crimp validation controls

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…