Quality Systems – Page 235

Dhf Missing during PAI readiness: batch release impact and documentation pack

Understanding the Impact of Missing DHF during PAI Readiness on Batch Release and Documentation In the high-stakes landscape of pharmaceutical manufacturing, the absence of a Design History File (DHF) during…

API starting material traceability gap after drying cycle optimization: risk-based approach to prevent repeat OOS across future API batches

Identifying and Addressing API Starting Material Traceability Gaps Following Drying Cycle Optimization Pharmaceutical manufacturing, especially in the production of active pharmaceutical ingredients (APIs), often encounters challenges that can lead to…

Vector potency drift during tech transfer: patient safety impact and disposition

Addressing Vector Potency Drift During Tech Transfer: Implications for Patient Safety and Disposition In the pharmaceutical industry, particularly in the development of Advanced Therapy Medicinal Products (ATMPs), vector potency drift…

Pump Actuation Failure in nasal spray filling: E&L risk assessment and documentation

Pump Actuation Failures in Nasal Spray Filling: A Comprehensive Investigation Guide In the pharmaceutical manufacturing landscape, ensuring the reliability of dosage forms is critical, particularly for devices such as nasal…

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…