pharma QA – Page 22 – Pharma.Tips

Biosimilar process change without bridging study after cell line or upstream change: risk assessment for critical quality attributes and clinical impact

Assessing Risks from Biosimilar Process Changes Without Bridging Studies After Cell Line Adjustments In the dynamic field of biosimilar production, any process change—especially those made without a bridging study—poses significant…

Radiochemical purity OOS during dispensing: patient safety assessment

Assessing and Managing Radiochemical Purity OOS Occurrences During Dispensing In the pharmaceutical manufacturing sector, particularly concerning radiopharmaceuticals, maintaining strict adherence to quality standards is essential for ensuring patient safety. Instances…

Labeling deviation in veterinary product manufacturing: GMP investigation and CAPA

“`html GMP Investigation and CAPA for Labeling Deviation in Veterinary Product Manufacturing Labeling deviations in veterinary product manufacturing can lead to significant compliance issues and potential regulatory actions. These deviations…

Biosimilar lot-to-lot variability trend (OOT) during biosimilar development: inspection-ready evidence pack for comparability and lifecycle management

Biosimilar Lot-to-Lot Variability Trending Investigation During Development In the pharmaceutical industry, ensuring the consistency and quality of biosimilars is critical for regulatory compliance and patient safety. One common issue that…

Half-life deviation during radiopharma production: CAPA under time-critical constraints

Investigating Half-Life Deviations in Radiopharmaceutical Production: CAPA for Time-Critical Situations In the high-stakes environment of radiopharmaceutical production, half-life deviations can pose significant challenges to product integrity and patient safety. Such…

Assay OOS during inspection prep: risk assessment for animal and food safety

Addressing Assay OOS During Inspection Preparation: A Comprehensive Investigation Framework In the dynamic landscape of pharmaceutical manufacturing, the emergence of out-of-specification (OOS) assays during inspection preparation can significantly hinder operations…

Biosimilar reference standard qualification gap during CPV trending review: how to handle outliers and statistics without triggering inspection findings

Biosimilar Reference Standard Qualification Gap During CPV Trending Review: Handling Outliers and Statistics to Avoid Inspection Findings In the complex world of pharmaceutical manufacturing, addressing deviations or out-of-specification (OOS) results…

Transport time excursion during transport to clinic: patient safety assessment

“`html Assessing Transport Time Excursions During Transport to Clinics: A Deep-Dive Investigation In pharmaceutical manufacturing, particularly when dealing with temperature-sensitive products such as radiopharmaceuticals, maintaining the integrity of the product…

Residue limit non-compliance during inspection prep: GMP investigation and CAPA

Addressing Residue Limit Non-Compliance During Inspection Preparation: A GMP Investigation Framework The detection of residue limit non-compliance during inspection preparation is a critical issue encountered in pharmaceutical manufacturing, particularly in…

Biosimilar lot-to-lot variability trend (OOT) during comparability protocol execution: how to handle outliers and statistics without triggering inspection findings

Managing OOT Trends During Biosimilar Comparability Protocol Execution When conducting comparability studies for biosimilars, one of the pressing challenges can be the emergence of out-of-trend (OOT) variability among lots. These…

Half-life deviation during transport to clinic: CAPA under time-critical constraints

Addressing Half-life Deviations During Clinic Transport: Timely CAPA Implementation In pharmaceutical manufacturing, particularly concerning radiopharmaceuticals, deviations related to half-life during transport can pose severe issues for compliance, efficacy, and patient…

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…