Investigation – Page 55

Cleaning Validation Gap during method transfer: device qualification and assembly controls

Investigating Cleaning Validation Gaps during Method Transfers In the dynamic landscape of pharmaceutical manufacturing, maintaining rigorous cleaning validation is crucial for ensuring product quality and patient safety. However, gaps in…

Dhf Missing for drug-device combination products: risk assessment and change control template

Addressing Missing DHF in Drug-Device Combination Products: A Comprehensive Investigation Guide In the dynamic landscape of pharmaceutical manufacturing, the integration of drug-device combination products presents unique challenges. One critical issue…

Dhf Missing after device supplier change: ownership between drug GMP and device QMS

Investigating the Missing DHF Post Device Supplier Change: Ensuring Compliance Between Drug GMP and Device QMS The change of a device supplier presents unique challenges in pharmaceutical manufacturing, particularly when…

Supplier Qualification Gap during tech transfer: batch release impact and documentation pack

Addressing Supplier Qualification Gaps during Tech Transfer: Impacts on Batch Release and Documentation In pharmaceutical manufacturing, the transfer of technology between suppliers can often lead to issues impacting batch release…

API residual palladium OOS during tech transfer to a new site: how to justify reprocessing vs rejection to FDA/EMA inspectors

Managing Out of Specification Residual Palladium Levels During API Tech Transfer to a New Site In the realm of pharmaceutical manufacturing, particularly during the tech transfer of active pharmaceutical ingredients…

Aseptic manipulation deviation during ATMP manufacturing: inspection-ready investigation package

Aseptic Manipulation Deviation During ATMP Manufacturing: A Comprehensive Investigation Framework Aseptic manipulation is critical in the production of Advanced Therapy Medicinal Products (ATMPs). Deviations in this area not only present…

E&L Failure in DPI manufacturing: device qualification and assembly controls

Addressing E&L Failure in DPI Manufacturing: Device Qualification and Assembly Controls The pharmaceutical industry is challenged constantly by various quality issues, one of which is extractables and leachables (E&L) failure…

Complaint Handling Deficiency during FDA inspection: batch release impact and documentation pack

Addressing Complaint Handling Deficiencies Identified During FDA Inspections In the highly regulated pharmaceutical landscape, any deficiency in complaint handling during FDA inspections can significantly impact batch release, leading to compliance…

Stability Failure for combination drug products: ownership between drug GMP and device QMS

Ownership in Stability Failures: Navigating GMP and Device QMS for Combination Drug Products Stability failures in combination drug products present unique challenges within pharmaceutical manufacturing environments. When such deviations occur,…

API residual solvent OOS after re-crystallization parameter adjustment: how to justify reprocessing vs rejection to FDA/EMA inspectors

“`html Managing API Residual Solvent OOS Results: Justifying Reprocessing vs Rejection In pharmaceutical manufacturing, the achievement of quality specifications is paramount. One common issue that can arise is the out-of-specification…

Cell viability failure during stability testing: regulatory risk assessment and CAPA

Analyzing Cell Viability Failures During Stability Testing: A Regulatory and CAPA Investigation Cell viability failures during stability testing can pose significant regulatory risks for pharmaceutical manufacturers, especially regarding Advanced Therapy…

E&L Failure during method transfer: device qualification and assembly controls

Addressing E&L Failures During Method Transfer in Device Qualification and Assembly Control Equipment and Leachables (E&L) failures during method transfers in pharmaceutical manufacturing can have far-reaching consequences, particularly for inhalation…