EMA – Page 175 – Pharma.Tips

Complaint Handling Deficiency after device supplier change: risk assessment and change control template

Investigation of Complaint Handling Deficiency Following Device Supplier Change In the pharmaceutical manufacturing landscape, a change in device supplier can introduce various challenges, particularly in terms of compliance and quality…

API co-crystal / salt form inconsistency during CPV trending review: supplier qualification gaps and incoming testing upgrades to close the loop

“`html Addressing Inconsistencies in API Co-Crystal and Salt Forms During CPV Trending Reviews Manufacturers often encounter discrepancies in the co-crystal or salt forms of Active Pharmaceutical Ingredients (APIs) during Continued…

Cryopreservation failure during FDA inspection readiness: regulatory risk assessment and CAPA

Cryopreservation Failure Risk Assessment During FDA Inspection Preparation Cryopreservation is critical in the pharmaceutical industry, particularly for Advanced Therapy Medicinal Products (ATMPs). However, failures in this process may pose significant…

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…

Tag: EMA

Complaint Handling Deficiency after device supplier change: risk assessment and change control template

API co-crystal / salt form inconsistency during CPV trending review: supplier qualification gaps and incoming testing upgrades to close the loop

Cryopreservation failure during FDA inspection readiness: regulatory risk assessment and CAPA

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

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

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

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

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

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

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

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

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