EMA – Page 179 – Pharma.Tips

Human Factors Validation Failure for drug-device combination products: what inspectors expect and how to fix it

Addressing Human Factors Validation Failures in Drug-Device Combination Products: A Practical Investigation Guide In the highly regulated landscape of pharmaceutical manufacturing, human factors validation failures in drug-device combination products present…

Design Controls Deficiency during FDA inspection: what inspectors expect and how to fix it

Identifying and Addressing Design Control Deficiencies Found During FDA Inspections In the complex world of pharmaceutical manufacturing, maintaining robust design controls is critical to ensuring compliance with regulatory requirements, particularly…

Oos Investigation for combination drug products: batch release impact and documentation pack

Investigating OOS Results in Combination Drug Products: Impacts on Batch Release and Documentation Quality Assurance in pharmaceutical manufacturing often hinges on effective monitoring and investigation of Out of Specification (OOS)…

API particle size distribution failure during FDA inspection readiness: risk-based approach to prevent repeat OOS across future API batches

“`html Addressing API Particle Size Distribution Failures for FDA Inspection Readiness: A Risk-Based Approach In today’s stringent regulatory environment, ensuring consistent particle size distribution (PSD) in Active Pharmaceutical Ingredients (APIs)…

Cryopreservation failure during tech transfer: inspection-ready investigation package

Cryopreservation Failure Investigations During Tech Transfer: Insight for Pharma Professionals Cryopreservation processes are crucial in the development of Advanced Therapy Medicinal Products (ATMPs), particularly during tech transfer stages. A failure…

Delivered Dose Uniformity Failure during inspection preparation: method variability vs true product failure assessment

Addressing Delivered Dose Uniformity Failures: Insights for Preparing for FDA Inspections In pharmaceutical manufacturing, ensuring the consistency and reliability of drug delivery systems is crucial, particularly for inhalation and nasal…

Stability Failure during tech transfer: risk assessment and change control template

Risk Assessment and Change Control for Stability Failures during Technical Transfer Stability failures during technical transfers pose significant risks to pharmaceutical manufacturers, impacting product quality, regulatory compliance, and market access.…

E&L Failure for nanoformulations: control strategy build-out for inspections

Managing Extractables and Leachables Failures in Nanoformulations: A Guide to Effective Control Strategies In the realm of pharmaceutical manufacturing, maintaining high standards of quality and compliance is non-negotiable. When issues…

API color / appearance change during stability pull at 6/12 months: supplier qualification gaps and incoming testing upgrades to close the loop

Investigating API Color Changes During Stability Pulls: Addressing Supplier Qualification Gaps In the lifecycle of Active Pharmaceutical Ingredients (APIs), color and appearance stability is a critical quality attribute. Unexpected deviations,…

Aseptic manipulation deviation during FDA inspection readiness: patient safety impact and disposition

Aseptic Manipulation Deviation Analysis for FDA Inspection Readiness: Ensuring Patient Safety and Compliance Aseptic manipulation deviations present serious challenges during FDA inspections, particularly due to their implications for patient safety…

Fine Particle Fraction Drift during EU/UK launch supply: FDA/MHRA investigation and corrective actions

Investigating Fine Particle Fraction Drift for EU/UK Launch Supply: A Deep Dive into FDA/MHRA Contexts In the pharmaceutical manufacturing landscape, issues such as fine particle fraction drift can pose significant…

Stability Failure for long-acting injectables: control strategy build-out for inspections

Addressing Stability Failures in Long-Acting Injectables: Building a Control Strategy for Inspections Stability failures in long-acting injectables pose significant challenges in pharmaceutical manufacturing, potentially disrupting the entire supply chain and…