Investigation – Page 49

Cryopreservation failure during FDA inspection readiness: patient safety impact and disposition

Cryopreservation Failures and Their Investigation During FDA Inspection Readiness Cryopreservation is a critical component in the manufacturing process of Advanced Therapy Medicinal Products (ATMPs). It preserves cells, tissues, and other…

Leakage Complaint in DPI manufacturing: E&L risk assessment and documentation

Understanding and Managing Leakage Complaints in DPI Manufacturing: A Comprehensive Investigation Leakage complaints in Dry Powder Inhaler (DPI) manufacturing can pose significant risks to both product quality and patient safety.…

Gmp Gap after device supplier change: ownership between drug GMP and device QMS

Investigating GMP Gaps Following a Change in Device Suppliers: Ensuring Compliance and Quality In the dynamic field of pharmaceutical manufacturing, a change in device suppliers can create significant quality and…

Regulatory Classification Issue after device supplier change: risk assessment and change control template

Addressing Regulatory Classification Issues Following a Device Supplier Change In the dynamic landscape of pharmaceutical manufacturing, the integration of new suppliers for critical components can inadvertently lead to regulatory classification…

Finished product serialization data mismatch during recall risk assessment: CAPA plan that inspectors accept (with effectiveness checks and due dates)

Addressing Serialization Data Mismatches in Recall Risk Assessments: An Investigation Approach In the realm of pharmaceutical manufacturing, one of the critical aspects of ensuring compliance and safeguarding product integrity is…

Aseptic manipulation deviation during ATMP manufacturing: patient safety impact and disposition

“`html Aseptic Manipulation Deviations in ATMP Manufacturing: Impact on Patient Safety and Disposition In the realm of Advanced Therapy Medicinal Products (ATMPs), aseptic manipulation is critical to ensure the integrity…

Pump Actuation Failure during EU/UK launch supply: FDA/MHRA investigation and corrective actions

Pump Actuation Failures: A Comprehensive Investigation for EU/UK Launch Supply Challenges Pump actuation failures can create significant challenges in pharmaceutical manufacturing, especially during critical launch phases like those seen in…

Complaint Handling Deficiency during lifecycle management: what inspectors expect and how to fix it

Addressing Deficiencies in Complaint Handling during Lifecycle Management in Pharma In the pharmaceutical industry, managing complaints effectively during the lifecycle of a product is crucial for maintaining quality and regulatory…

Post-Approval Change Failure for combination drug products: ownership between drug GMP and device QMS

Analyzing Post-Approval Change Failures in Combination Drug Products: Navigating GMP and Device Quality Management System Responsibilities In today’s complex landscape of pharmaceutical manufacturing, change management is critical, especially for combination…

Gmp Gap during lifecycle management: ownership between drug GMP and device QMS

Understanding the GMP Gap During Lifecycle Management: Bridging Drug GMP and Device QMS Responsibilities In the highly regulated world of pharmaceutical manufacturing, the interplay between drug Good Manufacturing Practices (GMP)…

Finished product transport excursion stability impact during routine batch release: CAPA plan that inspectors accept (with effectiveness checks and due dates)

Addressing Stability Impacts Due to Finished Product Transport Excursions During Routine Batch Release In pharmaceutical manufacturing, maintaining the integrity of finished products during transportation is critical. Encounters with temperature excursions…

Chain of identity breach during scale-up: inspection-ready investigation package

Inspection-Ready Investigation for Chain of Identity Breach during Scale-Up in Pharmaceutical Manufacturing In the pharmaceutical manufacturing landscape, particularly within the advanced therapy medicinal products (ATMPs) sector, maintaining the integrity of…