EMA – Page 150 – Pharma.Tips

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…

CCIT failure in ophthalmic/otic manufacturing: CAPA and sterility assurance controls

Understanding CCIT Failures in Ophthalmic and Otic Manufacturing: An Investigation Approach In the pharmaceutical industry, ensuring product sterility is paramount, particularly when manufacturing ophthalmic and otic products. One critical concern…

Biologic container closure integrity failure after equipment qualification update: viral safety and contamination response plan with inspection-ready evidence

Addressing Failures in Biologic Container Closure Integrity After Equipment Qualification Updates The integrity of container closures in biologics is paramount for ensuring product safety and regulatory compliance. A recent episode…

Stability failure with limited batches during lifecycle management: risk-based GMP justification

“`html Addressing Stability Failures with Limited Batches During Lifecycle Management In the dynamic environment of pharmaceutical manufacturing, stability failures can pose significant risks, particularly when these issues occur with a…

Sterility test failure during aseptic filling: FDA/EMA investigation expectations

Addressing Sterility Test Failures in Aseptic Filling: Investigation Framework and Operational Insights Sterility test failures during aseptic filling can significantly disrupt manufacturing processes, trigger regulatory scrutiny, and lead to product…

Biologic potency drift during commercial manufacturing campaign: investigation strategy aligned to FDA/EMA expectations and comparability principles

Investigating Biologic Potency Drift During Commercial Manufacturing: A Comprehensive Approach Biologic potency drift during a commercial manufacturing campaign can signal underlying issues that may compromise product quality and regulatory compliance.…

Specification justification gap during lifecycle management: CAPA with limited data sets

Managing Specification Justification Gaps in Lifecycle Management: Effective CAPA Strategies In pharmaceutical manufacturing, the lifecycle management of products, especially orphan drugs, presents unique challenges, particularly concerning specification justification gaps. Such…

Fill volume variability after packaging change: batch disposition and patient risk assessment

Investigating Variability in Fill Volume After a Change in Packaging: Batch Disposition and Risk Assessment In the pharmaceutical manufacturing landscape, fill volume variability following a packaging change poses significant challenges.…

Biologic stability failure (real-time/accelerated) during deviation investigation board review: CAPA package with CQA/CPP risk assessment and effectiveness verification

Addressing Biologic Stability Failure During Deviation Investigation Board Review Biologic stability failures, whether occurring during real-time or accelerated testing, present significant challenges to pharmaceutical manufacturers. Such incidents can affect product…

Stability failure with limited batches during small-batch manufacturing: FDA/EMA communication strategy

Addressing Stability Failures in Limited Batches during Small-Batch Manufacturing: An Investigation Approach Stability failures in small-batch manufacturing can pose significant challenges, particularly when regulatory scrutiny increases following deviations or out-of-specification…