Quality Systems – Page 226

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…

Fine Particle Fraction Drift in nasal spray filling: device qualification and assembly controls

Investigating Fine Particle Fraction Drift in Nasal Spray Filling Processes The manufacturing of nasal sprays requires precise controls over the fine particle fraction (FPF) to ensure efficacy and patient safety.…

Scale-Up Failure after formulation change: how to document for FDA/EMA/MHRA review

Addressing Scale-Up Failures Post-Formulation Change: A Comprehensive Investigation Guide for Regulatory Compliance In the dynamic landscape of pharmaceutical manufacturing, a scale-up failure after a formulation change can pose significant challenges,…

Oos Release Profile for modified release platforms: how to document for FDA/EMA/MHRA review

Addressing OOS Release Profiles for Modified Release Platforms: A Comprehensive Documentation Approach The pharmaceutical industry frequently encounters out-of-specification (OOS) results, especially when dealing with modified release platforms. These incidents can…

API impurity profile OOS after re-crystallization parameter adjustment: how to justify reprocessing vs rejection to FDA/EMA inspectors

Investigation of API Impurity Profile Out-of-Specification After Re-Crystallization Adjustments: A Practical Guide In the pharmaceutical manufacturing realm, the integrity of an Active Pharmaceutical Ingredient (API) is critical for ensuring product…