EMA – Page 184 – Pharma.Tips

Design Space Missing for long-acting injectables: risk assessment and validation impact analysis

Risk Assessment and Validation Impact Analysis of Missing Design Space for Long-Acting Injectables In the highly regulated landscape of pharmaceutical manufacturing, the absence of a defined design space can lead…

Method Transfer Failure during PAI readiness: control strategy build-out for inspections

Addressing Method Transfer Failures during PAI Readiness: Essential Strategies for Control Build-Out In the pharmaceutical manufacturing landscape, method transfer failures during Process Analytical Technology (PAT) process readiness can lead to…

API genotoxic impurity (GTI) breach after equipment maintenance intervention: how to justify reprocessing vs rejection to FDA/EMA inspectors

Addressing API Genotoxic Impurity Breach After Equipment Maintenance: An Investigation Approach In pharmaceutical manufacturing, identification of a genotoxic impurity (GTI) breach in Active Pharmaceutical Ingredients (APIs) following an equipment maintenance…

Microbial Limits Failure at accelerated stability: GMP documentation for FDA/EMA/MHRA review

Addressing Microbial Limits Failures during Accelerated Stability Testing In pharmaceutical manufacturing, microbial limits failures during accelerated stability testing represent a critical compliance issue with significant implications for product quality and…

Post-Approval Change Failure for innovative delivery systems: risk assessment and validation impact analysis

Analyzing the Impacts of Post-Approval Change Failures in Innovative Delivery Systems In the pharmaceutical manufacturing landscape, ensuring the efficacy and safety of innovative drug delivery systems post-approval is paramount. However,…

Control Strategy Weakness for modified release platforms: risk assessment and validation impact analysis

Addressing Control Strategy Weaknesses for Modified Release Platforms: A Comprehensive Investigation In the world of pharmaceutical manufacturing, particularly for modified release platforms, control strategy weaknesses can lead to significant quality…

Data Integrity Risk during lifecycle management: how to document for FDA/EMA/MHRA review

Managing Data Integrity Risks Throughout the Lifecycle: Documentation for Regulatory Review Data integrity remains a critical concern for pharmaceutical manufacturers, particularly during lifecycle management. The challenge often manifests as deviations,…

API water content (KF) OOS during FDA inspection readiness: how to justify reprocessing vs rejection to FDA/EMA inspectors

Handling OOS Results for API Water Content During FDA Inspection Readiness In the high-stakes world of pharmaceutical manufacturing, encountering Out-Of-Specification (OOS) results during routine checks is a critical issue that…

Sedimentation Oos in ear drop manufacturing: sanitation, water, and EM checks

Investigating the Causes and Solutions of Sedimentation OOS in Ear Drop Manufacturing In the highly regulated environment of pharmaceutical manufacturing, deviations, out-of-specification (OOS) results, and complaints must be investigated thoroughly…

Oos Release Profile for long-acting injectables: how to document for FDA/EMA/MHRA review

Documenting OOS Release Profiles for Long-Acting Injectables: Best Practices for Regulatory Review In the pharmaceutical manufacturing landscape, deviations from expected operational standards can profoundly impact product viability, particularly for long-acting…

Stability Failure after formulation change: control strategy build-out for inspections

Addressing Stability Failures Following Formulation Changes: An Investigation Framework In pharmaceutical manufacturing, formulation changes can lead to unexpected stability failures, prompting deviations or out-of-specification (OOS) results. Such incidents are critical…

API heavy metals / elemental impurities OOS after re-crystallization parameter adjustment: supplier qualification gaps and incoming testing upgrades to close the loop

Investigating OOS Results of API Heavy Metals After Re-crystallization Parameter Adjustments In pharmaceutical manufacturing, the identification of Out-of-Specification (OOS) results regarding heavy metals or elemental impurities post-re-crystallization presents significant compliance…