Deviation – Page 145

Supplier Qualification Gap for drug-device combination products: ownership between drug GMP and device QMS

Addressing the Supplier Qualification Gap for Drug-Device Combination Products The integration of drug-device combination products into the pharmaceutical landscape has introduced complexities that can lead to significant qualification gaps. These…

API particle size distribution failure after cleaning validation requalification: control strategy updates for CPPs/CMAs and continued process verification

Investigation of API Particle Size Distribution Failure Following Cleaning Validation Requalification In the dynamic environment of pharmaceutical manufacturing, ensuring the consistent quality of Active Pharmaceutical Ingredients (APIs) is essential. However,…

Aseptic manipulation deviation during stability testing: inspection-ready investigation package

Adequately Investigating Aseptic Manipulation Deviation During Stability Testing Aseptic manipulation deviations can pose serious challenges during stability testing, potentially compromising the integrity of Advanced Therapy Medicinal Products (ATMPs). As regulatory…

Delivered Dose Uniformity Failure during EU/UK launch supply: method variability vs true product failure assessment

Assessing Delivered Dose Uniformity Failures During EU/UK Launch Supply: Investigative Approaches In the pharmaceutical industry, maintaining the integrity of product quality throughout the manufacturing process is critical, especially during the…

Design Controls Deficiency for combination drug products: CAPA plan with effectiveness checks

Addressing Design Controls Shortcomings in Combination Drug Products: A Comprehensive CAPA Approach In the complex landscape of pharmaceutical manufacturing, deficiencies in design controls for combination drug products can lead to…

Complaint Handling Deficiency for combination drug products: what inspectors expect and how to fix it

Addressing Complaint Handling Deficiencies in Combination Drug Products: Insights for Effective Resolution In the highly regulated pharmaceutical landscape, addressing complaints effectively is paramount for maintaining product quality and ensuring patient…

API bulk density variability during EU GMP inspection preparation: root cause analysis (process vs lab) with CAPA effectiveness checks

Root Cause Analysis of API Bulk Density Variability During EU GMP Inspection Preparation Variability in bulk density of Active Pharmaceutical Ingredients (APIs) can pose significant challenges during EU GMP inspections.…

Cell viability failure during scale-up: regulatory risk assessment and CAPA

Addressing Cell Viability Failure During Scale-Up: A Structured Investigation Approach Cell viability failures during the scale-up phase of Advanced Therapy Medicinal Products (ATMPs) can pose significant challenges for pharmaceutical professionals.…

E&L Failure during method transfer: E&L risk assessment and documentation

E&L Risk Assessment and Documentation for Method Transfer Failures In the realm of pharmaceutical manufacturing, Extractables and Leachables (E&L) assessments are critical in ensuring safety and quality. However, during method…

Human Factors Validation Failure for drug-device combination products: what inspectors expect and how to fix it

Addressing Human Factors Validation Failures in Drug-Device Combination Products: A Practical Investigation Guide In the highly regulated landscape of pharmaceutical manufacturing, human factors validation failures in drug-device combination products present…

Design Controls Deficiency during FDA inspection: what inspectors expect and how to fix it

Identifying and Addressing Design Control Deficiencies Found During FDA Inspections In the complex world of pharmaceutical manufacturing, maintaining robust design controls is critical to ensuring compliance with regulatory requirements, particularly…

Oos Investigation for combination drug products: batch release impact and documentation pack

Investigating OOS Results in Combination Drug Products: Impacts on Batch Release and Documentation Quality Assurance in pharmaceutical manufacturing often hinges on effective monitoring and investigation of Out of Specification (OOS)…