Investigation – Page 53

API hygroscopicity-driven degradation after raw material supplier change: how to write a defensible deviation narrative for inspections

Defensible Deviation Narratives for API Hygroscopicity-Driven Degradation After Raw Material Supplier Changes In the pharmaceutical industry, undergoing a raw material supplier change can trigger significant quality concerns, particularly related to…

Cryopreservation failure during ATMP manufacturing: patient safety impact and disposition

Coping with Cryopreservation Failures in ATMP Manufacturing: An In-Depth Investigative Guide Cryopreservation is a critical process in the manufacturing of Advanced Therapy Medicinal Products (ATMPs). Failures during this stage can…

Cleaning Validation Gap during inspection preparation: E&L risk assessment and documentation

Addressing Cleaning Validation Gaps in Inspection Preparation and E&L Risk Assessment In the pharmaceutical manufacturing environment, ensuring compliance with regulatory standards for cleaning validation is critical, especially during inspection preparation.…

Post-Approval Change Failure during FDA inspection: risk assessment and change control template

Understanding and Addressing Post-Approval Change Failures during FDA Inspections In a regulatory landscape where compliance drives operational integrity, post-approval changes in pharmaceutical manufacturing often become focal points during FDA inspections.…

Regulatory Classification Issue for drug-device combination products: ownership between drug GMP and device QMS

Understanding the Regulatory Classification Challenges for Drug-Device Combination Products The complexities of regulatory classifications for drug-device combination products continue to pose significant challenges for pharmaceutical manufacturers. Misclassifications can result in…

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…

Tag: Investigation

API hygroscopicity-driven degradation after raw material supplier change: how to write a defensible deviation narrative for inspections

Cryopreservation failure during ATMP manufacturing: patient safety impact and disposition

Cleaning Validation Gap during inspection preparation: E&L risk assessment and documentation

Post-Approval Change Failure during FDA inspection: risk assessment and change control template

Regulatory Classification Issue for drug-device combination products: ownership between drug GMP and device QMS

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

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

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

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

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

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

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