In Good Laboratory Practice (GLP), meticulous attention to detail is paramount.
One crucial aspect that underscores the reliability and integrity of non-clinical studies is test item characterisation.
In this blog article, together with our GLP Auditor Michelle Anderson, we delve into the significance of test item characterisation in GLP, its methodology, and its pivotal role in ensuring precision and accuracy.
Understanding GLP Test Item Characterisation
Test item characterisation involves a comprehensive analysis and description of the test substance or product used in non-clinical studies.
Whether it’s a pharmaceutical compound, chemical substance, or biological material, understanding its properties, composition, and purity is essential for interpreting study results accurately and ensuring regulatory compliance.
The Importance of GLP Test Item Characterisation
Test item characterisation holds immense significance in GLP for the following reasons:
Data Interpretation: Accurate characterisation of the test item provides crucial context for interpreting study findings. It helps researchers understand how the properties of the test item may influence study outcomes and ensures that any observed effects can be attributed to the substance under investigation.
Regulatory Compliance: Regulatory agencies require comprehensive characterisation of test items to assess their safety, efficacy, and potential risks. Without proper characterisation, studies may fail to meet regulatory standards, leading to delays in product development or approval.
Risk Assessment: Understanding the composition and properties of the test item enables researchers to identify potential hazards and design appropriate risk mitigation strategies. This is particularly important in fields such as toxicology, where accurate risk assessment is critical for protecting human health and the environment.
Quality Control: Test item characterisation serves as a quality control measure, ensuring that the substance used in studies meets predetermined specifications and standards. It helps prevent contamination, batch-to-batch variability, and other factors that could compromise study integrity.
Methodology for GLP Test Item Characterisation
Test item characterisation typically involves a multi-faceted approach, incorporating various analytical techniques and methodologies. Key steps may include:
Identification: Determining the chemical identity of the test item using techniques such as mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, or infrared (IR) spectroscopy.
Purity Analysis: Assessing the purity of the test item to determine the concentration of the active ingredient and identify any impurities or contaminants present.
Physical Properties: Characterising the physical properties of the test item, including its appearance, solubility, stability, and particle size distribution.
Stability Studies: Conducting stability studies to evaluate the shelf-life and degradation kinetics of the test item under various storage conditions.
Biological Activity: Assessing the biological activity or pharmacological properties of the test item using in vitro or in vivo assays, where applicable.
Ensuring Compliance and Quality Assurance with GLP Standards
To ensure compliance with GLP standards and maintain the integrity of non-clinical studies, laboratories must adhere to rigorous quality assurance practices throughout the test item characterisation process. This includes:
Standardised Protocols: Developing and implementing standardised protocols and procedures for test item characterisation, ensuring consistency and reproducibility across studies.
Validation and Verification: Validating analytical methods and equipment used for test item characterisation to ensure accuracy, precision, and reliability of results.
Documentation and Record-Keeping: Maintaining detailed documentation and records of all test item characterisation activities, including raw data, protocols, reports, and any deviations or discrepancies encountered.
Quality Control Checks: Implementing quality control checks at each stage of the test item characterisation process to identify and mitigate potential sources of error or variability.
Conclusion
In Good Laboratory Practice, test item characterisation ensures the precision, accuracy, and reliability of non-clinical studies. By meticulously analysing and describing the properties of test substances, researchers can interpret study findings with confidence, adhere to regulatory requirements, and advance scientific knowledge with integrity.
In a world where precision is paramount, test item characterisation in GLP is not just a procedure; it’s a commitment to excellence and trustworthiness in scientific research.
About the Author
After many years of experience working in a variety of laboratories both in academia and for CRO’s, Michelle Anderson was the Quality Assurance Manager for a CRO, in which she managed all aspects of the Quality Management System, ensuring regulatory compliance of ISO 9001:2015, conducting internal and external audits as well as managing customer complaints and problem solving.
Before joining Arithmos’ UK Quality Assurance Team as GLP Auditor, Michelle was a GLP Auditor for a global life sciences and healthcare company.
How we can help you
At Arithmos, Good Laboratory Practice (GLP) auditors play a crucial role in ensuring that laboratories involved in non-clinical safety studies adhere to established quality standards and regulations.
Our GLP auditors are professionals with expertise in laboratory operations, quality management systems, regulatory compliance, and relevant scientific disciplines.
We conduct audits of laboratories to verify compliance with GLP regulations and guidelines established by regulatory agencies such as the MHRA (Medicines and Healthcare Products Regulatory Agency), OECD (Organisation for Economic Co-operation and Development), and the FDA (Food and Drug Administration).
In the fast-paced world of research sudden increases in workload are common. Whether due to seasonal fluctuations, unexpected project expansions, or regulatory demands, organisations must be prepared to scale up their operations swiftly and efficiently.
Arithmos offers a flexible and adaptable approach, able to seamlessly integrate into existing workflows, offering support and expertise precisely when and where it’s needed most.
Whether it’s augmenting staff for short-term projects or providing specialised assistance during peak periods, Arithmos can alleviate the burden and ensure continued compliance without compromising on quality.
About Arithmos
We are experts in the Life Sciences industry & Technology.
We are a long-standing Partner and Service Provider across Clinical Development, Regulatory and Compliance, Quality Management, Pharmacovigilance, and Medical Affairs domains.
We help pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
