Investigation – Page 48

Finished product disintegration failure after process parameter adjustment: how to build a deviation package that passes an inspection deep-dive

Understanding and Investigating Finished Product Disintegration Failures Following Process Parameter Adjustments In the highly regulated world of pharmaceutical manufacturing, even minor adjustments to process parameters can lead to significant deviations…

Vector potency drift during stability testing: patient safety impact and disposition

Investigating Vector Potency Drift During Stability Testing: Ensuring Patient Safety and Regulatory Compliance In the realm of Advanced Therapy Medicinal Products (ATMPs), vector potency drift during stability testing can lead…

Device-Drug Compatibility Failure in nasal spray filling: FDA/MHRA investigation and corrective actions

Understanding Device-Drug Compatibility Failures in Nasal Spray Filling: An Investigative Approach Device-drug compatibility failures can lead to significant challenges in pharmaceutical manufacturing, particularly when filling nasal spray units. Such failures…

Viscosity Drift after temperature excursion: process controls for moulding, filling, and storage

Understanding and Investigating Viscosity Drift Following Temperature Excursions in Pharmaceutical Manufacturing In the realm of pharmaceutical manufacturing, maintaining product quality and consistency is paramount. One pressing issue that arises frequently…

Oos Investigation during lifecycle management: risk assessment and change control template

OOS Investigation During Lifecycle Management: Implementing Risk Assessments and Change Control In the complex landscape of pharmaceutical manufacturing, Out of Specification (OOS) results can arise at any stage of product…

Finished product serialization data mismatch during complaint trending review: risk assessment for patient impact and field alert / recall triggers

Addressing Serialization Data Mismatch in Complaint Trending Reviews for Finished Products In the pharmaceutical manufacturing landscape, adherence to regulatory compliance is imperative. A recurring challenge identified is the mismatch of…

Cryopreservation failure during stability testing: patient safety impact and disposition

Cryopreservation Failures During Stability Testing: Evaluating Cause and Regulatory Compliance Cryopreservation is pivotal in the pharmaceutical manufacturing of advanced therapy medicinal products (ATMPs), particularly during stability testing. A failure in…

Valve Crimp Variability during method transfer: method variability vs true product failure assessment

Understanding Valve Crimp Variability during Method Transfer and How to Investigate It The pharmaceutical industry continuously faces challenges during method transfers, particularly regarding valve crimp variability. As manufacturers aim for…

Stability Failure during PAI readiness: batch release impact and documentation pack

Analyzing Stability Failures During PAI Readiness: Batch Release Implications and Documentation Needs When preparing for Product Application Inspection (PAI), pharmaceutical manufacturers must ensure that their products meet stringent stability criteria…

Gmp Gap during EMA/MHRA review: risk assessment and change control template

Identifying and Addressing GMP Gaps during EMA and MHRA Reviews In the highly regulated landscape of pharmaceutical manufacturing, GMP (Good Manufacturing Practice) compliance is paramount. However, various gaps can arise…

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

Investigating Assembly Process Validation Failures in Drug-Device Combination Products In the realm of pharmaceutical manufacturing, particularly concerning drug-device combination products, assembly process validation failures can lead to significant regulatory scrutiny…

Finished product preservative effectiveness test (PET) failure after process parameter adjustment: how to build a deviation package that passes an inspection deep-dive

Understanding and Investigating Finished Product Preservative Effectiveness Test Failures Following Process Parameter Adjustments In the pharmaceutical manufacturing landscape, a failure in the Finished Product Preservative Effectiveness Test (PET) can pose…