Deviation – Page 152

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…

E&L Failure for long-acting injectables: how to document for FDA/EMA/MHRA review

Documenting E&L Failures in Long-Acting Injectables for Regulatory Review As the pharmaceutical industry embraces advanced drug delivery systems such as long-acting injectables, the risk of element and leachables (E&L) failures…

Cpv Trending Gap for nanoformulations: decision tree for lab vs manufacturing root cause

Investigation Into Cpv Trending Gap for Nanoformulations: A Structured Approach to Root Cause Analysis In the realm of pharmaceutical manufacturing, particularly when dealing with advanced nanoformulations, the emergence of gaps…

API nitrosamine risk exceedance after cleaning validation requalification: GMP investigation checklist and batch disposition evidence pack

Checklist for Investigating API Nitrosamine Risk Exceedance Post-Cleaning Validation Requalification The identification of API nitrosamine risk exceedance after a cleaning validation requalification presents a significant challenge in pharmaceutical manufacturing. Such…

Preservative Miscalculation during inspection readiness: sanitation, water, and EM checks

Addressing Preservative Miscalculation During Inspection Readiness In the pharmaceutical manufacturing landscape, the precision of preservative calculations is vital, particularly during the inspection readiness phase. An oversight in this area can…