EMA – Page 174 – Pharma.Tips

Dhf Missing for drug-device combination products: ownership between drug GMP and device QMS

Understanding Ownership for Missing DHF in Drug-Device Combination Products In the world of pharmaceutical manufacturing, the integration of drug-device combination products presents unique challenges, especially in maintaining compliance with Good…

Stability Failure during EMA/MHRA review: batch release impact and documentation pack

Addressing Stability Failures during EMA and MHRA Reviews: Impact on Batch Release and Documentation Stability failures occurring during regulatory reviews can pose significant challenges for pharmaceutical manufacturers, particularly when they…

API assay drift during stability pull at 6/12 months: how to justify reprocessing vs rejection to FDA/EMA inspectors

Managing API Assay Drift During Stability Pulls at 6/12 Months: A Guide for Regulatory Justifications In the world of pharmaceutical manufacturing, deviations are inevitable, particularly when assessing the stability of…

Cell viability failure during scale-up: inspection-ready investigation package

“`html Investigation of Cell Viability Failure During Scale-Up: An Inspection-Ready Approach Cell viability failures during the scale-up of Advanced Therapy Medicinal Products (ATMPs) can significantly hinder production timelines and regulatory…

Leakage Complaint in nasal spray filling: FDA/MHRA investigation and corrective actions

Investigation of Leakage Complaints in Nasal Spray Filling Operations In the pharmaceutical manufacturing landscape, deviation complaints such as leakage in nasal spray filling can pose significant quality risk and regulatory…

Human Factors Validation Failure during tech transfer: risk assessment and change control template

Addressing Human Factors Validation Failures in Pharmaceutical Tech Transfers The pharmaceutical industry faces various challenges during the technical transfer of manufacturing processes, especially when it comes to Human Factors Validation.…

Human Factors Validation Failure during EMA/MHRA review: batch release impact and documentation pack

Exploring Human Factors Validation Failures during EMA and MHRA Reviews: Implications for Batch Release Documentation Human factors validation failures pose significant challenges for pharmaceutical companies, particularly during the rigorous EMA…

Software Validation Gap during PAI readiness: risk assessment and change control template

Identifying and Addressing Software Validation Gaps in PAI Readiness As pharmaceutical companies prepare for Pre-Approval Inspections (PAI), software validation becomes a critical focus. A software validation gap can significantly impact…

API batch-to-batch variability trend (OOT) after equipment maintenance intervention: regulatory impact assessment and change control remediation plan

Assessing API Batch-to-Batch Variability Trends After Equipment Maintenance: A Comprehensive Investigation In pharmaceutical manufacturing, maintaining consistent quality across batches of Active Pharmaceutical Ingredients (APIs) is crucial. Variability in product characteristics,…

Cryopreservation failure during tech transfer: patient safety impact and disposition

Cryopreservation Challenges During Technology Transfer: Understanding Patient Safety Risks and Proper Disposition Procedures Cryopreservation is a pivotal method in the manufacturing of Advanced Therapy Medicinal Products (ATMPs), ensuring the viability…

Fine Particle Fraction Drift in DPI manufacturing: how to trend dose delivery data in CPV

Addressing Fine Particle Fraction Drift in DPI Manufacturing: Effective Trending and Investigation Strategies The pharmaceutical industry often faces challenges in maintaining product quality and compliance, particularly in the manufacturing of…

E&L Failure for drug-device combination products: CAPA plan with effectiveness checks

Addressing E&L Failures in Drug-Device Combination Products: A Practical Investigation Guide In the pharmaceutical landscape, the interplay between drug formulations and their delivery mechanisms, particularly in drug-device combination products, poses…