EMA – Page 141 – Pharma.Tips

Residue limit non-compliance during stability studies: GMP investigation and CAPA

Investigating Residue Limit Non-Compliance During Stability Studies in Pharma Manufacturing In the highly regulated world of pharmaceutical manufacturing, ensuring compliance with residue limits during stability studies is critical. Non-compliance can…

Analytical similarity failure (Tier 1 CQAs) after cell line or upstream change: inspection-ready evidence pack for comparability and lifecycle management

Managing Analytical Similarity Failures Following Changes in Cell Lines or Upstream Processes In the dynamic field of pharmaceutical manufacturing, analytical similarity failures can present significant challenges, especially after changes to…

Half-life deviation during inspection readiness: regulatory deviation handling

Handling Regulatory Deviations Related to Half-life During Inspection Readiness In the realm of pharmaceutical manufacturing, deviations in critical parameters such as half-life can pose significant regulatory challenges, particularly when preparing…

Particulate matter OOS after packaging change: batch disposition and patient risk assessment

“` Addressing Out-of-Specification Results for Particulate Matter Post-Packaging Changes In pharmaceutical manufacturing, ensuring product quality and compliance with regulatory standards is critical. One common issue that can arise is the…

Biosimilar stability comparability failure during stability pull comparisons: FDA/EMA expectations for root cause, rework, and comparability justification

Understanding and Investigating Biosimilar Stability Comparability Failures During Stability Pull Comparisons In the intricate world of pharmaceutical manufacturing, maintaining the stability of biosimilars through rigorous testing is paramount. A common…

Sterility assurance gap during inspection readiness: regulatory deviation handling

Sterility Assurance Gaps Identified During Inspection Readiness: A Guide for Regulatory Deviation Handling In the highly regulated pharmaceutical manufacturing environment, the assurance of sterility is paramount, particularly when preparing for…

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

Assessing PET Failures in the Manufacturing of Ophthalmic and Otic Products: A Comprehensive Investigation Guide In pharmaceutical manufacturing, particularly within the ophthalmic and otic domains, the failure of products to…

Biosimilar stability comparability failure during analytical similarity assessment: inspection-ready evidence pack for comparability and lifecycle management

“`html Biosimilar Stability Comparability Failure During Analytical Similarity Assessment: An Investigation Framework In the realm of pharmaceutical development, particularly concerning biosimilars, the integrity of stability comparability during analytical similarity assessments…

Sterility assurance gap during dispensing: patient safety assessment

Evaluating Sterility Assurance Gaps During the Dispensing Process in Pharmaceutical Manufacturing In the highly regulated field of pharmaceutical manufacturing, particularly in the production of radiopharmaceuticals, the assurance of sterility during…

Sterility test failure during stability pull: CAPA and sterility assurance controls

Sterility Testing Failures during Stability Pulls: Investigating the Root Causes and Ensuring Compliance Sterility test failures during stability pulls can pose significant challenges in pharmaceutical manufacturing, especially for ophthalmic and…

Biosimilar potency OOS vs reference product after downstream resin change: risk assessment for critical quality attributes and clinical impact

Evaluating Biosimilar Potency Deviations Against Reference Products Following Downstream Resin Modifications In the realm of pharmaceutical manufacturing, the potency of biosimilars is paramount, especially when measured against reference products. A…

Sterility assurance gap during transport to clinic: regulatory deviation handling

Sterility Assurance Gaps in Transport to Clinics: Navigating Regulatory Deviation Handling In the highly regulated landscape of pharmaceutical manufacturing, deviations related to sterility assurance can lead to significant challenges, especially…