Quality Systems – Page 239

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…

Leakage Complaint during EU/UK launch supply: FDA/MHRA investigation and corrective actions

Addressing Leakage Complaints During the EU/UK Launch Supply: A Comprehensive Investigation and Corrective Framework In the highly regulated pharmaceutical landscape, a leakage complaint during a launch supply can raise significant…

E&L Failure during FDA inspection: what inspectors expect and how to fix it

E&L Study Failures: Strategies to Satisfy FDA Inspectors Extractables and leachables (E&L) testing has become an integral part of pharmaceutical manufacturing, particularly in relation to product safety and regulatory compliance.…

E&L Failure during EMA/MHRA review: batch release impact and documentation pack

Investigation of E&L Failures during EMA/MHRA Reviews and Their Impact on Batch Release In the pharmaceutical manufacturing environment, extractables and leachables (E&L) testing is critical to ensure product safety and…

Supplier Qualification Gap for drug-device combination products: ownership between drug GMP and device QMS

Addressing the Supplier Qualification Gap for Drug-Device Combination Products The integration of drug-device combination products into the pharmaceutical landscape has introduced complexities that can lead to significant qualification gaps. These…

API particle size distribution failure after cleaning validation requalification: control strategy updates for CPPs/CMAs and continued process verification

Investigation of API Particle Size Distribution Failure Following Cleaning Validation Requalification In the dynamic environment of pharmaceutical manufacturing, ensuring the consistent quality of Active Pharmaceutical Ingredients (APIs) is essential. However,…

Aseptic manipulation deviation during stability testing: inspection-ready investigation package

Adequately Investigating Aseptic Manipulation Deviation During Stability Testing Aseptic manipulation deviations can pose serious challenges during stability testing, potentially compromising the integrity of Advanced Therapy Medicinal Products (ATMPs). As regulatory…

Delivered Dose Uniformity Failure during EU/UK launch supply: method variability vs true product failure assessment

Assessing Delivered Dose Uniformity Failures During EU/UK Launch Supply: Investigative Approaches In the pharmaceutical industry, maintaining the integrity of product quality throughout the manufacturing process is critical, especially during the…

Design Controls Deficiency for combination drug products: CAPA plan with effectiveness checks

Addressing Design Controls Shortcomings in Combination Drug Products: A Comprehensive CAPA Approach In the complex landscape of pharmaceutical manufacturing, deficiencies in design controls for combination drug products can lead to…