EMA – Page 176 – Pharma.Tips

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…

Cryopreservation failure during ATMP manufacturing: inspection-ready investigation package

Investigation Package for Cryopreservation Failures in ATMP Manufacturing Cryopreservation is a critical process in the manufacturing of Advanced Therapy Medicinal Products (ATMPs), ensuring the viability of cellular and tissue-based therapies.…

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

Pump Actuation Failure in Nasal Spray Filling: Strategies for Trending Dose Delivery Data in Continuous Process Verification Pump actuation failure during nasal spray filling can lead to significant quality issues,…

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

Impact of Missing DHF during FDA Inspections on Batch Release Documentation In the highly regulated environment of pharmaceutical manufacturing, adherence to Good Manufacturing Practices (GMP) is crucial. One recurring issue…

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

Managing OOS Investigations During Tech Transfer: Bridging Drug GMP and Device QMS In the intricate world of pharmaceutical manufacturing and device integration, deviations and out-of-specification (OOS) results can pose significant…

API stability failure at accelerated conditions during FDA inspection readiness: supplier qualification gaps and incoming testing upgrades to close the loop

Addressing API Stability Failures during FDA Inspection Readiness with Supplier Qualification and Testing Enhancements In the pharmaceutical manufacturing landscape, ensuring the stability of Active Pharmaceutical Ingredients (APIs) is critical for…