EMA – Page 167 – Pharma.Tips

Finished product serialization data mismatch after method transfer to a new QC lab: updates to master batch record and in-process controls to prevent recurrence

Analyzing Serialization Data Mismatches Post Method Transfer to a New QC Lab The shift of method control to a new Quality Control (QC) laboratory can often unveil issues that impact…

Aseptic manipulation deviation during tech transfer: inspection-ready investigation package

A Comprehensive Investigation into Aseptic Manipulation Deviations during Tech Transfer Aseptic manipulation deviations during the tech transfer process can pose significant risks to the quality and safety of advanced therapy…

Pump Actuation Failure in MDI assembly: E&L risk assessment and documentation

Pump Actuation Failure in MDI Assembly: A Systematic Investigative Approach Pump actuation failure in Metered Dose Inhalers (MDIs) can pose significant risks, both in terms of product quality and patient…

Finished product assay OOS during CPV annual product review: risk assessment for patient impact and field alert / recall triggers

Out-of-Specification Findings During CPV Annual Product Review: A Pragmatic Investigation Guide In the dynamic world of pharmaceutical manufacturing, unexpected outcomes during finished product assay testing can signal significant underlying issues.…

Cryopreservation failure during FDA inspection readiness: inspection-ready investigation package

Cryopreservation Failure Investigation During FDA Inspection Readiness In an evolving pharmaceutical landscape, cryopreservation is crucial for preserving biologics, particularly in Advanced Therapy Medicinal Products (ATMPs). However, failures during cryopreservation can…

Cleaning Validation Gap during inspection preparation: method variability vs true product failure assessment

Addressing Cleaning Validation Gaps during Inspection Preparation: Method Variability versus True Product Failure Assessment In pharmaceutical manufacturing, achieving compliance with Good Manufacturing Practices (GMP) is non-negotiable, particularly during inspections by…

Finished product out-of-spec pH after process parameter adjustment: stability strategy adjustments and packaging risk mitigation steps

Investigating Out-of-Spec pH in Finished Products After Process Parameter Adjustments In pharmaceutical manufacturing, deviations from expected parameters can lead to significant quality concerns, especially when the finished product exhibits out-of-specification…

Vector potency drift during tech transfer: inspection-ready investigation package

Exploring Vector Potency Drift During Tech Transfer: A Comprehensive Investigation Framework In the intricate world of pharmaceutical manufacturing, particularly within Advanced Therapy Medicinal Products (ATMPs), one critical issue that can…

Apsd Oos during EU/UK launch supply: E&L risk assessment and documentation

A Comprehensive Investigation of APSD OOS During EU/UK Launch Supply Unexpected Out-of-Specification (OOS) results during the launch of Advanced Pharmaceutical Systems Delivery (APSD) in the EU and UK can complicate…

Post-Approval Change Failure during tech transfer: risk assessment and validation impact analysis

Understanding Post-Approval Change Failures During Tech Transfer: Risk Assessment and Validation Insights Post-approval change failures during tech transfer can lead to significant quality issues, production delays, and regulatory scrutiny. Pharmaceutical…

Finished product blend uniformity failure during routine batch release: how to defend specification setting and outlier handling during inspection

Addressing Blend Uniformity Failures in Routine Batch Release: A Comprehensive Investigation Guide Finished product blend uniformity failure can pose significant challenges during routine batch release. Such deviations not only jeopardize…

Cell viability failure during stability testing: patient safety impact and disposition

Understanding Cell Viability Failures during Stability Testing: Practical Investigation Strategies Cell viability failures during stability testing can pose significant challenges in pharmaceutical manufacturing, particularly for Advanced Therapy Medicinal Products (ATMPs).…