EMA – Page 146 – Pharma.Tips

Particulate matter OOS in ophthalmic/otic manufacturing: batch disposition and patient risk assessment

Exploring Particulate Matter OOS in Ophthalmic and Otic Manufacturing: Ensuring Batch Integrity and Risk Mitigation Encountering an Out of Specification (OOS) result for particulate matter in ophthalmic or otic products…

Biosimilar glycan profile mismatch during analytical similarity assessment: FDA/EMA expectations for root cause, rework, and comparability justification

“`html Root Cause Investigation of Biosimilar Glycan Profile Mismatch During Analytical Similarity Assessment Biosimilars represent a critical segment of the biopharmaceutical landscape, offering alternative therapeutic options once patents expire. However,…

Stability failure with limited batches during inspection readiness: risk-based GMP justification

Addressing Stability Failures with Limited Batches During Inspection Readiness Unexpected stability failures can pose significant challenges in pharmaceutical manufacturing, particularly when limited batches are involved. Understanding how to navigate such…

Particulate matter OOS during inspection readiness: CAPA and sterility assurance controls

Addressing Particulate Matter OOS during Inspection Readiness Through CAPA and Sterility Assurance Controls During the preparation for regulatory inspections, the appearance of particulate matter in pharmaceutical products can signal a…

Biosimilar aggregate level increase after cell line or upstream change: inspection-ready evidence pack for comparability and lifecycle management

Biosimilar Aggregate Level Increase Following Cell Line or Upstream Change: A Comprehensive Investigation Framework In the pharmaceutical manufacturing landscape, changes to cell lines or upstream processes can lead to significant…

Stability failure with limited batches during small-batch manufacturing: risk-based GMP justification

Addressing Stability Failures in Limited Batches During Small-Batch Manufacturing Stability failures in pharmaceutical products, particularly with limited batches during small-batch manufacturing, pose significant challenges for quality assurance and regulatory compliance.…

Particulate matter OOS during stability pull: CAPA and sterility assurance controls

Investigating Particulate Matter OOS During Stability Pulls: Containment and CAPA Strategies Identifying and addressing out-of-specification (OOS) results for particulate matter during stability pulls is critical in ensuring product safety and…

Biosimilar aggregate level increase during FDA/EMA scientific advice / meetings: CAPA strategy to restore similarity and prevent regulatory delays

“`html Investigating Increased Aggregate Levels in Biosimilars During FDA/EMA Scientific Meetings The development of biosimilars is inherently complex, and one of the significant challenges faced by manufacturers is the increase…

Stability failure with limited batches during inspection readiness: CAPA with limited data sets

Addressing Stability Failures with Limited Batches: A CAPA Approach In pharmaceutical manufacturing, stability failures can significantly impact product viability and regulatory compliance. This is particularly challenging when the failures occur…

CCIT failure during stability pull: batch disposition and patient risk assessment

Addressing CCIT Failures During Stability Pull: A Comprehensive Investigation Approach In the realm of pharmaceutical manufacturing, particularly for ophthalmic and otic products, failures during the Container Closure Integrity Testing (CCIT)…

Biosimilar stability comparability failure after cell line or upstream change: CAPA strategy to restore similarity and prevent regulatory delays

Biosimilar Stability and Comparability Failures: Investigative Strategies for Change Control In the complex world of pharmaceutical manufacturing, particularly in the realm of biosimilars, stability and comparability failures can pose significant…

Method variability OOS during regulatory review: FDA/EMA communication strategy

Addressing Method Variability OOS During Regulatory Review: A Practical Investigation Guide Variability in analytical methods can lead to Out of Specification (OOS) results, particularly during regulatory reviews by agencies such…