Quality Systems – Page 221

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…

Complaint Handling Deficiency during FDA inspection: CAPA plan with effectiveness checks

Addressing Complaint Handling Deficiencies during FDA Inspections: Formulating a CAPA Plan with Effectiveness Checks Pharmaceutical manufacturers often face challenges during inspections, particularly regarding complaint handling processes. Inefficient or ineffective systems…

Risk Management File Gap during lifecycle management: batch release impact and documentation pack

Addressing Gaps in Risk Management Files During Lifecycle Management: Implications for Batch Release and Documentation In the highly regulated pharmaceutical industry, the integrity of a product lifecycle management process is…

Software Validation Gap for drug-device combination products: ownership between drug GMP and device QMS

Addressing Software Validation Gaps in Drug-Device Combination Products In today’s pharmaceutical landscape, drug-device combination products pose unique challenges in maintaining compliance with Good Manufacturing Practice (GMP) standards and ensuring safety…

API starting material traceability gap after milling / micronization change: data integrity and chromatographic audit trail review steps

Investigating API Starting Material Traceability Gaps After Milling or Micronization Changes In the world of pharmaceutical manufacturing, maintaining the integrity of API starting materials is crucial. Occasional deviations can lead…