EMA – Page 147 – Pharma.Tips

PET failure during stability pull: CAPA and sterility assurance controls

Addressing PET Failures in Stability Pulls: A Comprehensive Investigation Approach Failures during stability pulls can have significant implications for pharmaceutical products, particularly in the context of sterility. This article presents…

Biosimilar functional assay variability (cell-based assay) during commercial launch readiness: FDA/EMA expectations for root cause, rework, and comparability justification

Addressing Variability in Biosimilar Functional Assays During Commercial Launch Readiness The complexity of biosimilars poses unique challenges, especially during the process of commercial launch readiness. One critical aspect is the…

Stability failure with limited batches during lifecycle management: CAPA with limited data sets

Addressing Stability Failures with Limited Batches During Lifecycle Management Stability failures within limited batch productions can present significant challenges for pharmaceutical manufacturers, especially during the lifecycle management of orphan drugs.…

PET failure after packaging change: CAPA and sterility assurance controls

Understanding PET Failure After Packaging Change: Investigation and CAPA Strategies Formulations packaged in Polyethylene Terephthalate (PET) are widely used in the pharmaceutical industry, particularly for ophthalmic and otic products. However,…

Biosimilar reference standard qualification gap during biosimilar development: risk assessment for critical quality attributes and clinical impact

Addressing Qualification Gaps in Biosimilar Development: A Structured Investigation Approach The qualification of reference standards in biosimilar development is critical to ensure that the biosimilar products align with regulatory expectations.…

Specification justification gap during small-batch manufacturing: CAPA with limited data sets

Addressing Specification Justification Gaps in Small-Batch Pharmaceutical Manufacturing In the evolving landscape of pharmaceutical manufacturing, particularly when dealing with orphan drugs, variability can often lead to deviations that require prompt…

CCIT failure during inspection readiness: batch disposition and patient risk assessment

Assessing CCIT Failures During Inspection Readiness: Strategies for Batch Disposition and Patient Risk Evaluation In the pharmaceutical manufacturing landscape, maintaining compliance and ensuring product integrity is paramount. One critical aspect…

Biosimilar method transfer failure across labs during FDA/EMA scientific advice / meetings: bridging study planning and regulatory communication strategy

Addressing Biosimilar Method Transfer Failures Observed Across Laboratories During Regulatory Meetings In the highly regulated landscape of pharmaceutical manufacturing, particularly within the realm of biosimilars, method transfer failures can significantly…

Method variability OOS during small-batch manufacturing: CAPA with limited data sets

“`html Understanding Method Variability OOS in Small-Batch Manufacturing: Effective CAPA Strategies During the production of orphan drugs in a small-batch environment, method variability can lead to out-of-specification (OOS) results, raising…

CCIT failure after packaging change: CAPA and sterility assurance controls

Investigating CCIT Failures Following Packaging Changes: A Focus on CAPA and Sterility Assurance Controls In the rapidly evolving landscape of pharmaceutical manufacturing, particularly in the production of ophthalmic and otic…

Biosimilar potency OOS vs reference product during comparability protocol execution: FDA/EMA expectations for root cause, rework, and comparability justification

Biosimilar Potency OOS Compared to Reference Product: Navigating FDA/EMA Protocols for Root Cause and Rework As the biosimilar landscape continues to evolve, the scientific and regulatory demands for comparability studies…

Supply interruption risk during inspection readiness: CAPA with limited data sets

“`html Managing Supply Interruption Risks in Pharmaceutical Manufacturing During Inspection Readiness In the pharmaceutical manufacturing landscape, maintaining uninterrupted supply chains is crucial for complying with Good Manufacturing Practices (GMP) and…