Investigation – Page 29

Sterility test failure after packaging change: FDA/EMA investigation expectations

Sterility Testing Failures Linked to Packaging Changes: Investigation Protocols In the pharmaceutical industry, maintaining sterility is non-negotiable, particularly for ophthalmic and otic products. A sterility test failure post-packaging change can…

Biologic container closure integrity failure during CPV trending review: patient safety impact assessment and batch disposition governance

Assessing Biologic Container Closure Integrity Failures in CPV Trending Reviews As the pharmaceutical industry advances, biologic products pose unique challenges, particularly concerning container closure integrity (CCI) failures. These failures, if…

Method variability OOS during inspection readiness: FDA/EMA communication strategy

Addressing Method Variability OOS During Inspection Preparation: A Comprehensive Investigation Approach In pharmaceutical manufacturing, method variability that results in Out of Specification (OOS) results can pose significant challenges, particularly during…

CCIT failure during aseptic filling: batch disposition and patient risk assessment

Investigating CCIT Failure in Aseptic Filling: A Comprehensive Approach to Batch Disposition and Risk Assessment In the high-stakes world of pharmaceutical manufacturing, particularly in aseptic filling environments, maintaining product sterility…

Biologic viral clearance validation gap after equipment qualification update: patient safety impact assessment and batch disposition governance

Addressing Biologic Viral Clearance Validation Gaps Post-Equipment Qualification Update In the highly regulated landscape of pharmaceutical manufacturing, particularly within the realm of biologics, validation of viral clearance is of paramount…

Supply interruption risk during lifecycle management: CAPA with limited data sets

Managing Supply Interruption Risks Throughout Product Lifecycle: An Investigative Approach Supply interruptions in the pharmaceutical manufacturing sector can pose significant risks, particularly for orphan drugs that target small patient populations.…

Fill volume variability in ophthalmic/otic manufacturing: batch disposition and patient risk assessment

Understanding Fill Volume Variability in Ophthalmic and Otic Manufacturing: An Investigation Approach Fill volume variability in ophthalmic and otic manufacturing can pose serious risks to both batch disposition and end-user…

Biologic comparability failure after process change after filling line intervention: how to justify rework/reprocessing vs rejection for biologic lots

Assessing Biologic Comparability Failures Following Process Changes: Justifying Rework versus Rejection Pharmaceutical companies frequently encounter challenges when adapting processes, particularly in the production of biologics. One critical concern is biologic…

Specification justification gap during small-batch manufacturing: FDA/EMA communication strategy

Exploring Specification Justification Gaps in Small-Batch Pharmaceutical Manufacturing In the increasingly regulated world of pharmaceutical manufacturing, small-batch production often presents unique challenges, particularly regarding specification justification. This gap can lead…

PET failure during aseptic filling: batch disposition and patient risk assessment

Investigating PET Failure During Aseptic Filling: Batch Disposition and Patient Risk Assessment In the pharmaceutical industry, the integrity of aseptic processing is paramount, particularly in the production of ophthalmic and…

Biologic stability failure (real-time/accelerated) during tech transfer to a CMO: viral safety and contamination response plan with inspection-ready evidence

Addressing Stability Failures of Biologics During Tech Transfer to CMOs: An Inspection-Ready Approach Biologic stability failures—whether in real-time or accelerated conditions—can pose significant challenges during tech transfer to Contract Manufacturing…

Specification justification gap during regulatory review: CAPA with limited data sets

Addressing Gaps in Specification Justification During Regulatory Reviews In the evolving field of pharmaceutical manufacturing, the pressure for stringent compliance during regulatory reviews has never been greater. A notable challenge…