Deviation – Page 142

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…

Tag: Deviation

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

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

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

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

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

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

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

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

Cryopreservation failure during ATMP manufacturing: inspection-ready investigation package

Pump Actuation Failure in nasal spray filling: how to trend dose delivery data in CPV

Dhf Missing during FDA inspection: batch release impact and documentation pack

Oos Investigation during tech transfer: ownership between drug GMP and device QMS