EMA – Page 182 – Pharma.Tips

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…

Leakage Complaint during EU/UK launch supply: device qualification and assembly controls

Investigating Leakage Complaints During EU and UK Launch Supplies In the highly regulated environment of pharmaceutical manufacturing, even minor complaints can signal significant underlying issues. A leakage complaint during product…

Method Transfer Failure during lifecycle management: decision tree for lab vs manufacturing root cause

Analyzing Method Transfer Failure during Lifecycle Management: A Practical Guide to Root Cause Analysis In pharmaceutical manufacturing, method transfer failures can create significant challenges during the lifecycle management of products.…

E&L Failure for modified release platforms: regulatory-ready investigation and CAPA plan

Regulatory-Ready Investigation and CAPA Plan for E&L Failures in Modified Release Platforms Environmental and Leachables (E&L) failures in modified release platforms are critical issues that can lead to significant regulatory…

Data Integrity Risk during tech transfer: how to document for FDA/EMA/MHRA review

How to Navigate Data Integrity Risks During Tech Transfer for Compliance with FDA, EMA, and MHRA Data integrity risks during tech transfer present significant challenges for pharmaceutical manufacturers. With increasing…

API microbial limit failure during commercial scale manufacture: data integrity and chromatographic audit trail review steps

Addressing API Microbial Limit Failures During Commercial Scale Manufacture: A Comprehensive Investigative Approach Microbial contamination during the manufacturing of Active Pharmaceutical Ingredients (APIs) can lead to significant issues, including batch…