EMA – Page 143 – Pharma.Tips

Particulate matter OOS during stability pull: batch disposition and patient risk assessment

Addressing Particulate Matter OOS during Stability Pull: Investigative Strategies for Batch Disposition In the landscape of pharmaceutical manufacturing, the detection of particulate matter during stability pull poses significant challenges for…

Biosimilar reference standard qualification gap during analytical similarity assessment: decision tree for lab method variability vs true product differences

Addressing Gaps in Biosimilar Reference Standard Qualification During Analytical Similarity Assessment In the highly regulated environment of pharmaceutical manufacturing, ensuring the integrity of biosimilar products is paramount. Recently, inconsistencies in…

Transport time excursion during transport to clinic: CAPA under time-critical constraints

Addressing Transport Time Excursions During Transport to Clinics: A Comprehensive Investigation Transporting radiopharmaceuticals to clinics is a time-sensitive process critical for maintaining product integrity and patient safety. However, deviations can…

Sterility test failure during inspection readiness: FDA/EMA investigation expectations

Sterility Testing Failure During Inspection Readiness: Navigating FDA/EMA Investigation Standards In the complex world of pharmaceutical manufacturing, a sterility test failure can lead to significant operational and regulatory challenges, especially…

Biosimilar lot-to-lot variability trend (OOT) during analytical similarity assessment: decision tree for lab method variability vs true product differences

Biosimilar Lot-to-Lot Variability Trends During Analytical Similarity Assessment: A Decision Tree for Navigating Lab Method Variability Versus True Product Differences Biosimilars have emerged as critical components of therapeutic strategies, yet…

Half-life deviation during transport to clinic: regulatory deviation handling

Handling Half-life Deviations in Radiopharmaceuticals During Transit The transport and handling of radiopharmaceuticals are critically regulated processes due to their innate instability and short half-lives. A half-life deviation detected during…

CCIT failure after packaging change: batch disposition and patient risk assessment

Understanding CCIT Failure Post-Packaging Change: Batch Disposition and Risk Assessment The successful packaging of pharmaceutical products is critical to ensuring patient safety and maintaining product integrity. A deviation or failure…

Biosimilar stability comparability failure during biosimilar development: how to build a defensible similarity narrative with data integrity controls

Biosimilar Stability Comparability Failure During Development: Building a Defensible Similarity Narrative The manufacturing of biosimilars presents unique challenges, particularly concerning stability comparability. Failures in demonstrating stability equivalence can lead to…

Transport time excursion during inspection readiness: patient safety assessment

Assessing Patient Safety Linked to Transport Time Excursions During Inspection Readiness In the pharmaceutical manufacturing landscape, especially concerning radiopharmaceuticals, understanding the implications of transport time excursions during inspection readiness is…

Particulate matter OOS during inspection readiness: FDA/EMA investigation expectations

Investigating Particulate Matter OOS Findings During Inspection Readiness in Pharmaceutical Manufacturing In the realm of pharmaceutical manufacturing, the presence of particulate matter can lead to Out-of-Specification (OOS) results, posing substantial…

Biosimilar stability comparability failure after manufacturing site change: inspection-ready evidence pack for comparability and lifecycle management

Addressing Biosimilar Stability Comparability Failures Due to Manufacturing Site Changes Biosimilars are a pivotal element of modern therapeutics, but changes in their manufacturing sites can lead to stability comparability failures.…

Radiochemical purity OOS during transport to clinic: regulatory deviation handling

Handling Regulatory Deviations Related to OOS Radiochemical Purity During Transport to Clinic The pharmaceutical industry often faces challenges related to out-of-specification (OOS) results, and radiopharmaceuticals, in particular, can be susceptible…