Quality Systems – Page 227

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,…

Design Space Missing for modified release platforms: regulatory-ready investigation and CAPA plan

Addressing the Absence of Design Space in Modified Release Platforms: A Comprehensive Investigation The pharmaceutical industry continually faces the challenges of ensuring product quality and regulatory compliance, particularly for modified…

E&L Failure for long-acting injectables: control strategy build-out for inspections

Addressing E&L Failures in Long-Acting Injectables: Building an Inspection-Ready Control Strategy Extractables and Leachables (E&L) are critical concerns in the pharmaceutical industry, particularly for long-acting injectables. When an E&L failure…

API nitrosamine risk exceedance during commercial scale manufacture: GMP investigation checklist and batch disposition evidence pack

GMP Investigation Checklist for API Nitrosamine Risk Exceedance During Commercial Scale Manufacturing The presence of nitrosamines in Active Pharmaceutical Ingredients (APIs) has posed significant risks to pharmaceutical manufacturers, often leading…

Chain of identity breach during scale-up: patient safety impact and disposition

Investigating Chain of Identity Breach During Scale-Up: Ensuring Patient Safety and Proper Disposition In the pharmaceutical manufacturing process, particularly when developing Advanced Therapy Medicinal Products (ATMPs), ensuring the integrity of…