Quality Systems – Page 218

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…

API hygroscopicity-driven degradation after raw material supplier change: how to write a defensible deviation narrative for inspections

Defensible Deviation Narratives for API Hygroscopicity-Driven Degradation After Raw Material Supplier Changes In the pharmaceutical industry, undergoing a raw material supplier change can trigger significant quality concerns, particularly related to…

Cryopreservation failure during ATMP manufacturing: patient safety impact and disposition

Coping with Cryopreservation Failures in ATMP Manufacturing: An In-Depth Investigative Guide Cryopreservation is a critical process in the manufacturing of Advanced Therapy Medicinal Products (ATMPs). Failures during this stage can…

Cleaning Validation Gap during inspection preparation: E&L risk assessment and documentation

Addressing Cleaning Validation Gaps in Inspection Preparation and E&L Risk Assessment In the pharmaceutical manufacturing environment, ensuring compliance with regulatory standards for cleaning validation is critical, especially during inspection preparation.…

Post-Approval Change Failure during FDA inspection: risk assessment and change control template

Understanding and Addressing Post-Approval Change Failures during FDA Inspections In a regulatory landscape where compliance drives operational integrity, post-approval changes in pharmaceutical manufacturing often become focal points during FDA inspections.…