Investigation – Page 52

Software Validation Gap for drug-device combination products: batch release impact and documentation pack

Addressing Software Validation Gaps in Drug-Device Combination Products: Implications for Batch Release and Documentation In the world of pharmaceutical manufacturing, ensuring the quality and compliance of drug-device combination products is…

API assay drift after raw material supplier change: data integrity and chromatographic audit trail review steps

Investigation Steps for API Assay Drift Following a Raw Material Supplier Change In the pharmaceutical manufacturing landscape, changes in raw material suppliers can provoke unexpected deviations, notably API assay drift.…

Chain of identity breach during stability testing: patient safety impact and disposition

Managing a Chain of Identity Breach During Stability Testing: Implications and Actionable Steps In the pharmaceutical manufacturing landscape, ensuring the integrity of product identity during stability testing is critical to…

Spray Pattern Failure during inspection preparation: method variability vs true product failure assessment

Understanding Spray Pattern Failures: A Comprehensive Investigation Approach In pharmaceutical manufacturing, ensuring the consistency and reliability of dosage forms is critical. One such challenge arises during the production of inhalation…

Design Controls Deficiency during EMA/MHRA review: ownership between drug GMP and device QMS

Understanding Design Controls Deficiency during EMA/MHRA Review: Bridging Drug GMP and Device QMS Design controls deficiencies during EMA or MHRA reviews can lead to significant setbacks in the pharmaceutical product…

Assembly Process Validation Failure during lifecycle management: batch release impact and documentation pack

Addressing Assembly Process Validation Failures Throughout Lifecycle Management: Understanding Batch Release Impacts and Documentation Requirements Pharmaceutical manufacturing is an intricate process where adherence to Good Manufacturing Practices (GMP) is paramount.…

Assembly Process Validation Failure for combination drug products: risk assessment and change control template

Understanding Assembly Process Validation Failures for Combination Drug Products: A Comprehensive Investigation Guide In the highly regulated environment of pharmaceutical manufacturing, validation failures can occur during various stages of the…

API heavy metals / elemental impurities OOS after cleaning validation requalification: root cause analysis (process vs lab) with CAPA effectiveness checks

Root Cause Analysis for Out-of-Specification Heavy Metals in API Post Cleaning Validation In the world of pharmaceutical manufacturing, ensuring the integrity of Active Pharmaceutical Ingredients (APIs) is paramount. One common…

Vector potency drift during stability testing: inspection-ready investigation package

Handling Vector Potency Drift During Stability Testing: A Comprehensive Investigation Guide In the pharmaceutical manufacturing landscape, particularly when dealing with Advanced Therapy Medicinal Products (ATMPs), the phenomenon of vector potency…

Fine Particle Fraction Drift during EU/UK launch supply: E&L risk assessment and documentation

Investigating Fine Particle Fraction Drift in EU/UK Launch Supply In pharmaceutical manufacturing, ensuring the consistency and efficacy of inhalation products is critical, particularly during pivotal launch phases. One pressing issue…

Complaint Handling Deficiency during lifecycle management: ownership between drug GMP and device QMS

Addressing Deficiencies in Complaint Handling during Lifecycle Management In the pharmaceutical industry, addressing complaints effectively is a vital aspect of maintaining compliance and ensuring product quality. When deficiencies in handling…

Regulatory Classification Issue during PAI readiness: risk assessment and change control template

Understanding Regulatory Classification Issues during PAI Readiness: A Practical Approach In the pharmaceutical industry, the readiness for Pre-Approval Inspections (PAI) can uncover regulatory classification issues with significant implications. Without proper…