FDA – Page 264 – Pharma.Tips

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…

Vector potency drift during ATMP manufacturing: inspection-ready investigation package

Investigating Vector Potency Drift in ATMP Manufacturing: A Practical Guide Vector potency drift during Advanced Therapy Medicinal Product (ATMP) manufacturing poses significant risks to product consistency, safety, and regulatory compliance.…

Apsd Oos in DPI manufacturing: device qualification and assembly controls

Addressing Apsd Oos in DPI Manufacturing: Device Qualification and Assembly Controls In the domain of pharmaceutical manufacturing, especially in the production of dry powder inhalers (DPIs), Out of Specification (OOS)…

Gmp Gap for drug-device combination products: risk assessment and change control template

Identifying and Addressing GMP Gaps in Drug-Device Combination Products In the realm of pharmaceutical manufacturing, specifically concerning drug-device combination products, the compliance with Good Manufacturing Practices (GMP) is crucial. However,…

E&L Failure for drug-device combination products: what inspectors expect and how to fix it

Addressing E&L Failures in Drug-Device Combination Products: Inspection Expectations and Remedial Actions As the complexities of drug-device combination products evolve, so too do the challenges associated with extractables and leachables…

Complaint Handling Deficiency during PAI readiness: what inspectors expect and how to fix it

Addressing Complaint Handling Deficits During PAI Readiness: Inspector Expectations and Effective Solutions In the ever-evolving landscape of pharmaceutical manufacturing, preparing for a Pre-Approval Inspection (PAI) brings public health scrutiny to…

API endotoxin risk in sterile API after drying cycle optimization: how to justify reprocessing vs rejection to FDA/EMA inspectors

Managing API Endotoxin Risks in Sterile API During Drying Cycle Optimization In the pharmaceutical industry, ensuring that active pharmaceutical ingredients (APIs) are free from contamination is paramount. The presence of…

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

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

Vector potency drift during ATMP manufacturing: inspection-ready investigation package

Apsd Oos in DPI manufacturing: device qualification and assembly controls

Gmp Gap for drug-device combination products: risk assessment and change control template

E&L Failure for drug-device combination products: what inspectors expect and how to fix it

Complaint Handling Deficiency during PAI readiness: what inspectors expect and how to fix it

API endotoxin risk in sterile API after drying cycle optimization: how to justify reprocessing vs rejection to FDA/EMA inspectors

Chain of identity breach during scale-up: regulatory risk assessment and CAPA

Device-Drug Compatibility Failure in DPI manufacturing: E&L risk assessment and documentation

Dhf Missing during lifecycle management: batch release impact and documentation pack

Risk Management File Gap during FDA inspection: what inspectors expect and how to fix it