EMA – Page 177 – Pharma.Tips

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…

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

Assessing Chain of Identity Breaches During Scale-Up: A Practical Investigation Approach In pharmaceutical manufacturing, particularly with advanced therapy medicinal products (ATMPs), a breach in the chain of identity during scale-up…

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

Investigating Device-Drug Compatibility Issues in Dry Powder Inhaler Manufacturing Device-drug compatibility failures in dry powder inhalers (DPIs) can lead to significant quality issues, impacting both product efficacy and patient safety.…

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

Addressing the Impact of Missing Documentation in Lifecycle Management for Batch Release In pharmaceutical manufacturing, robust lifecycle management is critical to ensure compliance, quality, and traceability of products. A growing…

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

During a recent FDA inspection, a pharmaceutical manufacturing facility encountered significant scrutiny due to a Risk Management File Gap. This gap highlighted deficiencies in their documentation practices related to risk…

API residual palladium OOS during routine release testing: supplier qualification gaps and incoming testing upgrades to close the loop

Addressing Out-of-Specification Residual Palladium Levels in Active Pharmaceutical Ingredients In the pharmaceutical industry, ensuring the integrity and quality of Active Pharmaceutical Ingredients (APIs) is paramount for regulatory compliance and patient…

Aseptic manipulation deviation during tech transfer: patient safety impact and disposition

Aseptic Manipulation Deviation During Tech Transfer: Evaluating Impact and Disposition Aseptic manipulation deviations during the tech transfer process can significantly compromise product integrity, posing risks to product quality and patient…