Deviation – Page 147

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…

Stability Failure for nanoformulations: regulatory-ready investigation and CAPA plan

Regulatory-Ready Investigation of Stability Failures in Nanoformulations In the highly specialized field of pharmaceutical manufacturing, particularly concerning advanced drug delivery systems such as nanoformulations, stability issues can pose significant challenges.…

API nitrosamine risk exceedance during tech transfer to a new site: control strategy updates for CPPs/CMAs and continued process verification

Managing Nitrosamine Risks During API Tech Transfers: Investigative Approaches for Control Strategies Nitrosamine impurities in active pharmaceutical ingredients (APIs) have emerged as a significant concern within the pharmaceutical industry, especially…

Cell viability failure during FDA inspection readiness: patient safety impact and disposition

Addressing Cell Viability Failures During FDA Inspection Preparedness Cell viability plays a crucial role in the manufacturing of Advanced Therapy Medicinal Products (ATMPs). A failure to demonstrate acceptable cell viability…