ReviewThe Indian journal of medical research2026
Navigating risk in biological quality testing: A guide for emerging laboratories.
Review in The Indian journal of medical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biological products are inherently complex and highly sensitive to variations in testing conditions, rendering quality control (QC) testing laboratories particularly vulnerable to high-impact operational, analytical, and biosafety risks. Despite the emphasis on risk-based thinking in international standards, a structured laboratory-specific framework for identifying, assessing, and mitigating risks in biological product QC testing remains insufficiently articulated. This article presents a simplified approach for proactive identification of testing-related and occupational health risks, along with their mitigation and conversion into opportunities. The concept aligns with internationally accepted standards, including ISO/IEC Guide 51, ISO 31000:2018, ISO/IEC 17025:2017, and ICH Q9 guidelines. Implementation of this framework enhances the reliability of results, strengthens regulatory compliance, and improves patient and occupational safety. By addressing the gap in structured risk assessment for biological QC laboratories, the article provides practical guidance for implementing ISO/IEC 17025:2017 Clause 8.5 and enables continuous improvement through systematically converting identified risks into opportunities.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.