FDA – Page 279 – Pharma.Tips

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…

Delivered Dose Oos in aerosol filling: method variability vs true product failure assessment

Delivered Dose OOS in Aerosol Filling: Evaluating Method Variability vs. True Product Failure The occurrence of Out of Specification (OOS) results in aerosol filling processes presents significant challenges for pharmaceutical…

Spray Pattern Failure during EU/UK distribution qualification: packaging integrity and transport risk assessment

Addressing Spray Pattern Failures in the EU/UK Distribution Qualification of Aerosols In pharmaceutical manufacturing, ensuring the integrity of aerosol products during distribution qualifications is crucial. A recent incident involving a…