Deviation – Page 150

Ivivc Mismatch after formulation change: regulatory-ready investigation and CAPA plan

Investigating Ivivc Mismatch Following a Formulation Change: A Regulatory-Ready Approach Pharmaceutical professionals often encounter the challenge of in vitro–in vivo correlation (IVIVC) mismatches after formulation changes, leading to potential regulatory…

API bulk density variability after solvent change in last step: how to justify reprocessing vs rejection to FDA/EMA inspectors

Investigating Variability in API Bulk Density After Last-Step Solvent Change: A Practical Guide for Compliance Justification In the highly regulated landscape of pharmaceutical manufacturing, variability in active pharmaceutical ingredients (APIs)…

Aseptic manipulation deviation during FDA inspection readiness: regulatory risk assessment and CAPA

Aseptic Manipulation Deviation During FDA Inspection Readiness: A Comprehensive Investigation Approach Aseptic manipulation deviations present significant risks during FDA inspections, especially concerning regulatory compliance. Such deviations can lead to serious…

Sedimentation Oos at accelerated stability: sanitation, water, and EM checks

Understanding Sedimentation OOS at Accelerated Stability: A Comprehensive Investigation Framework In the highly regulated pharmaceutical landscape, deviations and out-of-specification (OOS) results pose significant challenges. One such scenario is the observation…

Design Space Missing during PAI readiness: how to document for FDA/EMA/MHRA review

Documenting Missing Design Space for PAI Readiness: A Structured Investigation Approach In the realm of pharmaceutical manufacturing, ensuring that the Design Space is accurately documented ahead of Pre-Approval Inspections (PAI)…

Method Transfer Failure during PAI readiness: decision tree for lab vs manufacturing root cause

Addressing Method Transfer Failures during PAI Readiness: An Investigation Guide In the pharmaceutical industry, method transfer is a critical process, especially during Pre-Approval Inspections (PAI). A failure in this process…

Design Space Missing during PAI readiness: control strategy build-out for inspections

Addressing Missing Design Space During PAI Readiness: Building Out Control Strategies for Inspections In the pharaceutical manufacturing sector, preparing for a Pre-Approval Inspection (PAI) can be complicated, especially when a…

API endotoxin risk in sterile API after drying cycle optimization: control strategy updates for CPPs/CMAs and continued process verification

Optimizing the Drying Cycle for Sterile API: Investigating Endotoxin Risks and Control Strategy Updates In pharmaceutical manufacturing, the optimization of the drying cycle for active pharmaceutical ingredients (APIs) can introduce…

Fill Volume Variability during line setup: investigation steps with CAPA evidence

Investigating Fill Volume Variability in Pharmaceutical Line Setup: A Comprehensive Approach Fill volume variability during line setup can lead to significant compliance challenges in pharmaceuticals, potentially resulting in Out of…

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…