Deviation – Page 147

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…

Chain of identity breach during tech transfer: regulatory risk assessment and CAPA

Understanding Chain of Identity Breach in Tech Transfer: A Methodical Approach to Investigation and CAPA In the world of pharmaceutical manufacturing, especially concerning Advanced Therapy Medicinal Products (ATMPs), the integrity…

Apsd Oos in DPI manufacturing: FDA/MHRA investigation and corrective actions

Addressing Apsd Oos in DPI Manufacturing: A Comprehensive Investigation Guide Deviations and out-of-specification (OOS) results in dry powder inhaler (DPI) manufacturing can significantly impact product quality and regulatory compliance. Ensuring…

Post-Approval Change Failure during lifecycle management: decision tree for lab vs manufacturing root cause

Investigating Post-Approval Change Failures in Pharmaceutical Lifecycle Management In the pharmaceutical industry, post-approval change failures during lifecycle management can significantly hinder product quality, compliance, and regulatory standing. Such failures often…

E&L Failure for long-acting injectables: decision tree for lab vs manufacturing root cause

Decision Path for Identifying Root Cause of E&L Failure in Long-Acting Injectables In pharmaceutical manufacturing, extractables and leachables (E&L) testing plays a critical role in ensuring the safety and efficacy…