Deviation – Page 148

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…

Scale-Up Failure for innovative delivery systems: control strategy build-out for inspections

Scale-up failures in pharmaceutical manufacturing can lead to costly delays and regulatory scrutiny, especially when associated with innovative delivery systems. In this piece, we will guide you through a comprehensive…

API flow property failure after re-crystallization parameter adjustment: how to justify reprocessing vs rejection to FDA/EMA inspectors

Addressing API Flow Property Failures Following Re-Crystallization Parameter Adjustments In the realm of pharmaceutical manufacturing, the integrity of Active Pharmaceutical Ingredients (APIs) is paramount to ensuring product quality and compliance…

Chain of identity breach during ATMP manufacturing: inspection-ready investigation package

Investigation of Chain of Identity Breach During ATMP Manufacturing The intricate world of Advanced Therapy Medicinal Products (ATMPs) presents unique challenges in pharmaceutical manufacturing. A breach in the chain of…

E&L Failure during inspection preparation: method variability vs true product failure assessment

Assessing E&L Failures in Inspection Preparation: Understanding Method Variability and Authentic Product Failure Environmental and Leachable (E&L) failures during the inspection preparation phase can pose significant challenges during pharmaceutical manufacturing,…