EMA – Page 180 – Pharma.Tips

Method Transfer Failure during lifecycle management: control strategy build-out for inspections

Addressing Method Transfer Failures in Lifecycle Management for Inspection Readiness In pharmaceutical manufacturing, method transfer failures can lead to significant compliance risks during inspections by regulatory bodies like the FDA,…

E&L Failure for long-acting injectables: regulatory-ready investigation and CAPA plan

Investigation and CAPA Planning for E&L Failure in Long-Acting Injectables Extractables and leachables (E&L) failures in long-acting injectables can jeopardize product quality and patient safety, posing significant challenges for pharmaceutical…

API hygroscopicity-driven degradation after re-crystallization parameter adjustment: risk-based approach to prevent repeat OOS across future API batches

“`html Investigating API Degradation: How to Mitigate Risks from Re-Crystallization Adjustments In pharmaceutical manufacturing, particularly concerning Active Pharmaceutical Ingredients (APIs), maintaining product integrity through proper processes is critical. One common…

Cell viability failure during ATMP manufacturing: regulatory risk assessment and CAPA

Assessing Cell Viability Failures in ATMP Manufacturing: A Systematic Investigation Approach Cell viability failures during the manufacturing of Advanced Therapy Medicinal Products (ATMPs) pose significant regulatory risks and can lead…

Pump Actuation Failure during EU/UK launch supply: device qualification and assembly controls

Pump Actuation Failure Investigation During EU/UK Launch Supply In the rapidly evolving landscape of pharmaceutical manufacturing, pump actuation failures can critically impede the successful launch of products, especially in highly…

Control Strategy Weakness for long-acting injectables: control strategy build-out for inspections

Identifying and Addressing Control Strategy Weaknesses in Long-Acting Injectables In the realm of pharmaceutical manufacturing, the integrity of the control strategy is paramount, especially for complex dosage forms like long-acting…

Oos Release Profile during lifecycle management: regulatory-ready investigation and CAPA plan

Investigation of OOS Release Profiles in Lifecycle Management: A Regulatory-Ready Approach The presence of Out-of-Specification (OOS) results during the lifecycle management of pharmaceutical products poses significant challenges for manufacturing and…

API residual palladium OOS during process validation campaign: how to write a defensible deviation narrative for inspections

Addressing OOS Results for API Residual Palladium During Process Validation Campaigns In the pharmaceutical manufacturing landscape, delivering high-quality active pharmaceutical ingredients (APIs) is paramount. When an out-of-specification (OOS) result for…

Vector potency drift during FDA inspection readiness: inspection-ready investigation package

Investigating Vector Potency Drift During FDA Inspection Readiness In the context of advanced therapy medicinal products (ATMPs), the drift in vector potency is a critical issue that can pose substantial…

Device-Drug Compatibility Failure in nasal spray filling: how to trend dose delivery data in CPV

Addressing Device-Drug Compatibility Issues in Nasal Spray Filling: Trending Dose Delivery Data in Continuous Process Verification In pharmaceutical manufacturing, device-drug compatibility failure during the filling of nasal sprays can lead…

Control Strategy Weakness for nanoformulations: risk assessment and validation impact analysis

Addressing Control Strategy Weaknesses in Nanoformulations: A Comprehensive Investigation In the world of pharmaceutical manufacturing, ensuring that the control strategies for advanced drug delivery systems, such as nanoformulations, are robust…

Method Transfer Failure for modified release platforms: regulatory-ready investigation and CAPA plan

Investigating and Addressing Method Transfer Challenges in Modified Release Platforms Method transfer failures in modified release platforms pose significant challenges for pharmaceutical manufacturers aiming to achieve regulatory compliance. These failures…