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Navigating risk in biological quality testing: A guide for emerging laboratories.
Rashmi Shrivastava1, Sanchi Goel1, Niharika Trivedi1
1Quality Management Unit, National Institute of Biologicals, Noida, Uttar Pradesh, India.
The Indian Journal of Medical Research
|June 4, 2026
Summary
Biological product quality control (QC) labs face risks. This study offers a simplified framework for identifying, assessing, and mitigating these risks, enhancing safety and compliance.
Area of Science:
- Biotechnology
- Laboratory Science
- Risk Management
Background:
- Biological product quality control (QC) laboratories are susceptible to operational, analytical, and biosafety risks due to product complexity and testing sensitivity.
- Existing international standards emphasize risk-based thinking, yet a structured, laboratory-specific framework for biological QC risk management is lacking.
- This gap hinders consistent risk identification, assessment, and mitigation, impacting result reliability and safety.
Purpose of the Study:
- To present a simplified, structured framework for the proactive identification, assessment, and mitigation of risks in biological product QC testing.
- To provide practical guidance for addressing testing-related and occupational health risks within a laboratory setting.
- To facilitate the conversion of identified risks into opportunities for continuous improvement in QC processes.
Main Methods:
- Development of a simplified risk management framework tailored for biological product QC laboratories.
- Alignment of the framework with international standards: ISO/IEC Guide 51, ISO 31000:2018, ISO/IEC 17025:2017, and ICH Q9.
- Focus on proactive identification of testing and occupational health risks and their subsequent mitigation strategies.
Main Results:
- A structured approach for identifying, assessing, and mitigating risks in biological QC testing is proposed.
- The framework enhances the reliability of QC testing results and strengthens regulatory compliance.
- Implementation leads to improved patient and occupational safety within the laboratory environment.
Conclusions:
- The proposed framework addresses the need for structured risk assessment in biological QC laboratories.
- It provides practical guidance for implementing ISO/IEC 17025:2017 Clause 8.5, focusing on risk mitigation and opportunity conversion.
- Systematic risk management enhances laboratory operations, ensuring product quality and safety.
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