EMA – Page 142 – Pharma.Tips

Sterility test failure in ophthalmic/otic manufacturing: batch disposition and patient risk assessment

Sterility Test Failures in Ophthalmic and Otic Manufacturing: Investigation and Risk Assessment In the pharmaceutical manufacturing sector, particularly within ophthalmic and otic product lines, the integrity of sterility tests is…

Analytical similarity failure (Tier 1 CQAs) after downstream resin change: FDA/EMA expectations for root cause, rework, and comparability justification

Addressing Analytical Similarity Failures Following Downstream Resin Changes: A Comprehensive Investigation Framework In biopharmaceutical development, changes in the manufacturing process, such as the alteration of downstream resins, can trigger analytical…

Sterility assurance gap during transport to clinic: CAPA under time-critical constraints

Addressing Sterility Assurance Gaps During Transport to Clinic: A CAPA Investigation Guide In the pharmaceutical industry, ensuring the integrity of product sterility is paramount, particularly when dealing with radiopharmaceuticals where…

Fill volume variability during aseptic filling: FDA/EMA investigation expectations

Addressing Variability in Fill Volume During Aseptic Filling: A Comprehensive Investigation Approach Fill volume variability during aseptic filling is a common concern in pharmaceutical manufacturing, especially for products such as…

Analytical similarity failure (Tier 1 CQAs) during comparability protocol execution: CAPA strategy to restore similarity and prevent regulatory delays

“`html Addressing Analytical Similarity Failures in Comparability Protocols: A Strategic Investigation and CAPA Approach Pharmaceutical manufacturers often face critical challenges during the comparability assessment of biosimilars, especially in relation to…

Radiochemical purity OOS during radiopharma production: CAPA under time-critical constraints

Addressing Out-of-Specification Radiochemical Purity in Radiopharmaceutical Production: A Structured Investigation In the complex world of radiopharmaceutical manufacturing, ensuring compliance with radiochemical purity specifications is crucial for patient safety and regulatory…

Fill volume variability after packaging change: FDA/EMA investigation expectations

Addressing Fill Volume Variability After Packaging Changes: Insights on Investigation Standards In pharmaceutical manufacturing, deviations such as fill volume variability can dramatically affect product quality and regulatory compliance. When a…

Biosimilar potency OOS vs reference product after downstream resin change: CAPA strategy to restore similarity and prevent regulatory delays

Investigating Biosimilar Potency OOS in Relation to Reference Products After Downstream Resin Modification When a biosimilar product fails to demonstrate potent equivalence to its reference product, particularly following changes in…

Transport time excursion during dispensing: CAPA under time-critical constraints

Addressing Transport Time Excursions in Dispensing: Effective CAPA Strategies In the fast-paced world of pharmaceutical manufacturing, transport time excursions during the dispensing of products, particularly radiopharmaceuticals, can pose significant challenges.…

PET failure during inspection readiness: CAPA and sterility assurance controls

Addressing PET Failure During Inspection Readiness: A CAPA and Sterility Assurance Framework In the realm of pharmaceutical manufacturing, particularly in the production of ophthalmic and otic products, the sterility assurance…

Biosimilar residual HCP / DNA OOS during CPV trending review: CAPA strategy to restore similarity and prevent regulatory delays

Addressing OOS Results for Biosimilar Residual HCP and DNA Through Effective CAPA Strategies Unplanned deviations, such as Out of Specification (OOS) results for biosimilar residual host cell proteins (HCP) and…

Radiochemical purity OOS during inspection readiness: regulatory deviation handling

Investigation into Deviation Handling for Radiochemical Purity OOS During Inspection Readiness The pharmaceutical manufacturing environment is heavily regulated, particularly when it comes to radiopharmaceuticals, where radiochemical purity is critical for…