EMA – Page 139 – Pharma.Tips

Assay OOS in veterinary product manufacturing: regulatory communication strategy

Addressing Out of Specification Results during Veterinary Product Manufacturing: An Investigation Approach In the dynamic field of pharmaceutical manufacturing, particularly within veterinary products, encountering Out of Specification (OOS) results during…

Biosimilar charge variant profile drift during FDA/EMA scientific advice / meetings: how to build a defensible similarity narrative with data integrity controls

Biosimilar Charge Variant Profile Drift: Constructing a Defensible Similarity Narrative During FDA/EMA Reviews The complexity of biosimilar development presents numerous challenges, particularly concerning the charge variant profile of the molecules.…

Radiochemical purity OOS during dispensing: CAPA under time-critical constraints

Investigating Out-of-Specification (OOS) Radiochemical Purity During Dispensing: CAPA in Time-Critical Scenarios Out-of-Specification (OOS) results related to radiochemical purity during the dispensing process pose a significant challenge in pharmaceutical manufacturing, especially…

Labeling deviation during stability studies: regulatory communication strategy

Addressing Labeling Deviations During Stability Studies: A Strategic Investigation Approach In the realm of pharmaceutical manufacturing, the integrity of labeling during stability studies is critical. A labeling deviation can lead…

Biosimilar lot-to-lot variability trend (OOT) after cell line or upstream change: FDA/EMA expectations for root cause, rework, and comparability justification

Biosimilar Lot-to-Lot Variability Trends Post-Cell Line or Upstream Changes: Expectations and Investigative Approaches In the dynamic arena of biosimilar manufacturing, fluctuations in lot-to-lot variability can pose significant quality challenges, particularly…

Half-life deviation during transport to clinic: patient safety assessment

Assessing Half-Life Deviation During Clinic Transport: An Investigation Approach In pharmaceutical manufacturing, particularly in the field of radiopharmaceuticals, deviations during transport can pose significant risks to patient safety. A half-life…

Assay OOS during regulatory submission: GMP investigation and CAPA

Investigation of Assay OOS Results during Regulatory Submission: A GMP Approach In the rigorous landscape of pharmaceutical manufacturing, encountering out-of-specification (OOS) assay results during regulatory submission can trigger significant repercussions.…

Analytical similarity failure (Tier 1 CQAs) during FDA/EMA scientific advice / meetings: FDA/EMA expectations for root cause, rework, and comparability justification

Understanding and Addressing Analytical Similarity Failures During FDA/EMA Meetings In the complex landscape of pharmaceutical manufacturing, particularly in developing biosimilars, analytical similarity failures can pose significant challenges. These failures often…

Radiochemical purity OOS during transport to clinic: patient safety assessment

Investigating Radiochemical Purity OOS During Transport to Clinic: A Comprehensive Approach Ensuring the radiochemical purity of radiopharmaceuticals during transport to clinics is critical for patient safety and regulatory compliance. Out-of-Specification…

Microbial limits failure during regulatory submission: risk assessment for animal and food safety

Investigating Microbial Limits Failure in Regulatory Submissions: A Comprehensive Approach Microbial limits failures during regulatory submissions pose serious risks to patient safety, animal health, and overall product compliance. Such incidents…

Biosimilar immunogenicity risk signal after downstream resin change: bridging study planning and regulatory communication strategy

Addressing Immunogenicity Risks After Changes in Downstream Resin: An Investigation Framework The biosimilar industry is currently navigating complex challenges, particularly concerning immunogenicity risks associated with changes in manufacturing processes. Suppose…

Radiochemical purity OOS during radiopharma production: regulatory deviation handling

Investigating Out of Specification Radiochemical Purity in Radiopharmaceutical Production Out of Specification (OOS) results in radiochemical purity during radiopharmaceutical production can compromise the integrity of both the product and the…