Deviation – Page 151

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…

Phase Separation during method transfer: investigation steps with CAPA evidence

Investigating Phase Separation during Method Transfer: Effective Investigation Steps and CAPA Solutions Phase separation occurring during method transfer is a vital issue that can compromise product integrity in pharmaceutical manufacturing,…

Scale-Up Failure for long-acting injectables: risk assessment and validation impact analysis

Addressing Scale-Up Failure in Long-Acting Injectables: A Comprehensive Investigation Approach Scale-up failures in the manufacturing of long-acting injectables can lead to significant deviations from expected performance, impacting product quality and…

Ivivc Mismatch during PAI readiness: regulatory-ready investigation and CAPA plan

Understanding Ivivc Mismatch during PAI Readiness: A Comprehensive Investigation Approach In the intricate landscape of pharmaceutical manufacturing, ensuring that in vitro-in vivo correlation (IVIVC) aligns during Pharmacokinetic Assessment for submission…

Ivivc Mismatch for modified release platforms: how to document for FDA/EMA/MHRA review

Documenting Ivivc Mismatch for Modified Release Platforms for Regulatory Review The pharmaceutical landscape continually evolves, with modified release platforms presenting unique challenges for quality control (QC) and quality assurance (QA)…

API batch-to-batch variability trend (OOT) during process validation campaign: root cause analysis (process vs lab) with CAPA effectiveness checks

Root Cause Analysis of API Batch-to-Batch Variability Trends During Process Validation Campaigns In pharmaceutical manufacturing, ensuring consistent product quality is paramount. Variability in Active Pharmaceutical Ingredient (API) batches can lead…

Viscosity Drift in ear drop manufacturing: sanitation, water, and EM checks

Investigating Viscosity Drift in Ear Drop Manufacturing: Focus on Sanitation, Water Quality, and Environmental Monitoring Manufacturing ear drops involves meticulous attention to formulations, as variations in viscosity can compromise product…

Control Strategy Weakness during lifecycle management: control strategy build-out for inspections

Addressing Control Strategy Weakness in Lifecycle Management: Preparing for Inspections In the highly regulated pharmaceutical industry, the effectiveness of a control strategy is critical to ensure product quality and compliance…

Cpv Trending Gap during tech transfer: control strategy build-out for inspections

Investigating Cpv Trending Gaps During Tech Transfer: Building an Inspection-Ready Control Strategy In the high-stakes environment of pharmaceutical manufacturing, the successful transfer of processes and technology between departments or facilities…

API nitrosamine risk exceedance after milling / micronization change: risk-based approach to prevent repeat OOS across future API batches

Managing API Nitrosamine Risk Exceedance Post-Milling Change: An Effective Investigation Approach The emergence of nitrosamine risk exceedance following a milling or micronization process change poses significant challenges in the pharmaceutical…

Phase Separation after supplier change: GMP documentation for FDA/EMA/MHRA review

Addressing Phase Separation Issues Due to Supplier Changes: A Comprehensive Investigation Guide In pharmaceutical manufacturing, the introduction of a new supplier can pose significant challenges, including product quality deviations like…

Control Strategy Weakness after formulation change: decision tree for lab vs manufacturing root cause

Addressing Control Strategy Weakness Following a Formulation Change: A Decision-Making Framework for Root Cause Investigation In the dynamic environment of pharmaceutical manufacturing, formulation changes can often trigger unexpected control strategy…