Investigation – Page 28

Radiochemical purity OOS during radiopharma production: patient safety assessment

Assessing Radiochemical Purity OOS in Radiopharmaceutical Production: A Comprehensive Investigation In pharmaceutical manufacturing, particularly within radiopharmaceutical production, the integrity of radiochemical purity is critical for ensuring patient safety and compliance…

PET failure during inspection readiness: FDA/EMA investigation expectations

Investigating PET Failure During Inspection Readiness: Compliance and CAPA Strategies In the pharmaceutical industry, particularly in the manufacturing of ophthalmic and otic products, maintaining inspection readiness is critical to ensuring…

Biosimilar stability comparability failure after downstream resin change: bridging study planning and regulatory communication strategy

Addressing Biosimilar Stability Comparability Failures Caused by Downstream Resin Changes In the ever-evolving landscape of biopharmaceutical manufacturing, the integrity of biosimilar stability is paramount. A recent increase in reports regarding…

Sterility assurance gap during transport to clinic: patient safety assessment

Assessing Sterility Assurance Gaps in Transport to Clinics for Radiopharmaceuticals In the pharmaceutical manufacturing sector, particularly concerning radiopharmaceuticals, ensuring sterility during transport is critical to maintaining patient safety. A gap…

Fill volume variability during stability pull: FDA/EMA investigation expectations

Addressing Fill Volume Variability During Stability Pulls: Investigation and Solutions In pharmaceutical manufacturing, particularly within the scope of ophthalmic and otic products, fill volume variability can be a critical deviation,…

Biosimilar reference standard qualification gap during stability pull comparisons: inspection-ready evidence pack for comparability and lifecycle management

Addressing Qualification Gaps in Biosimilar Reference Standards During Stability Pull Comparisons In the pharmaceutical manufacturing landscape, particularly for biosimilars, inconsistencies in reference standard qualification can lead to significant compliance issues.…

Transport time excursion during inspection readiness: regulatory deviation handling

Handling Transport Time Excursions During Inspection Readiness: A Structured Investigation Approach Transport time excursions during inspection readiness can pose significant challenges to pharmaceutical manufacturers, particularly in the production of radiopharmaceuticals.…

Sterility test failure during inspection readiness: batch disposition and patient risk assessment

Sterility Test Failures: Investigating Risks and Ensuring Compliance In the highly regulated landscape of pharmaceutical manufacturing, sterility testing plays a critical role in ensuring the safety and integrity of products,…

Biosimilar aggregate level increase after downstream resin change: CAPA strategy to restore similarity and prevent regulatory delays

Addressing Aggregate Level Increase in Biosimilars Following Downstream Resin Changes The emergence of biosimilars has been a pivotal development in the pharmaceutical industry, offering an alternative to biologics. However, changes…

Radiochemical purity OOS during dispensing: regulatory deviation handling

Managing Deviations in Radiochemical Purity OOS During Dispensing In the complex world of pharmaceutical manufacturing, particularly in radiopharmaceuticals, unexpected out-of-specification (OOS) results can significantly disrupt operations. One such instance is…

CCIT failure during stability pull: FDA/EMA investigation expectations

“`html Addressing Failures in CCIT During Stability Pull: Insights for FDA and EMA Compliance In the realm of pharmaceutical manufacturing, particularly in the production of ophthalmic and otic products, a…

Biosimilar aggregate level increase after manufacturing site change: how to build a defensible similarity narrative with data integrity controls

Identifying and Addressing Increased Biosimilar Aggregate Levels Post-Manufacturing Site Change The transition to a new manufacturing site can trigger numerous process-related challenges, especially in the biopharmaceutical sector. One critical issue…