The Importance of Formulation Analysis in GLP Toxicology

There is a specific set of standards that must be adhered to for optimal results when it comes to any scientific research. Good laboratory practice (GLP), for example, is vital for ensuring dose formulation analysis is accurate, which is critical for the success of any new product. 

Formulation analysis forms one part of the process of toxicology studies. Here, we ask experts why GLP toxicology is so essential and what should be considered when seeking a lab to provide testing services for your next study.

What Is GLP and What Does it Encompass?

In a laboratory setting, GLP stands for good laboratory practice. This encompasses a set of standards and principles that ensure any results of studies are achieved reliably, with integrity and at a high standard.

This is crucial when conducting studies relating to the toxicology testing of cosmetics, chemicals and pharmaceuticals, for example.

Some of the critical aspects of GLP include:

• Accurate documentation – this must cover all aspects of a study, including design, raw data and final results.
• Quality assurance – there must be procedures in place that are adhered to and continually monitored to ensure the reliability and quality of data.
• SOPs – there must be a set of standard operating procedures for every step of the process involved in a study.
• Training – all workers must be adequately trained and qualified for their specific tasks.
• Correct study management – there must be management and oversight of studies that follow specific protocols. These must be continually monitored throughout the course of a study.
• Data archiving – the way data is stored and archived must be strictly organised, as this will allow for the study's reconstruction and traceability.
• Quality control – there must be a strict set of quality control measures in order to verify the accuracy and reliability of the test itself and the data it produces.

Why GLP is Crucial

In toxicology, formulation analysis refers to the examination and assessment of the stability, homogeneity, concentration, and composition of a test article. When conducting toxicology studies to evaluate the safety of a substance, GLP must be front and centre to avoid any dangerous impacts on those it is meant to assist.

GLP provides a good base for ensuring accurate formulation analysis according to the following components:

• Composition – when analysing a test article, it is vital to be able to work out the exact composition. This includes measuring active ingredients and any additives, for example. Awareness of all of the minor ingredients will be crucial to measuring the potential toxic effects of the whole formula. GLP will help to ensure this. 
• Concentration – ensuring that the intended doses are administered during a toxicology study is vital. This can help to measure the relationship between the dose and the toxicological response. Inaccurate data could have devastating effects. With GLP, all data will be subject to strict analysis and checking to avoid this. 
• Homogeneity – there must be a uniform distribution of the active ingredient throughout the formulation. GLP can ensure this is the case. If a formula is not correctly mixed, each dose may be different when administered to study subjects, which can significantly impact the reliability of the study.
• Stability – it is vital to measure the deterioration or stability of a formula, which should include various conditions, including handling, transportation and storage. Lab conditions are very different to those in the real world, and any good lab knows that this is just as crucial as any other part of toxicology analysis.

Meeting regulatory compliance

According to the publication NonClinical Dose Formulation Analysis Method Validation and Sample Analysis (2010), certain criteria are required to be met for GLP toxicology studies. There needs to be a careful balance between accuracy, precision and stability. This is especially important considering the unique characteristics of such formulations and their required storage conditions.

No matter where you are based in the world, there will be specific regular standards that you must meet when analysing formulations.  For example, bodies such as the European Medicines Agency (EMA) Principles of Good Laboratory Practice, The Japanese Ministry of Health, Labour and Welfare Regulation, Reg 21, and the US Food and Drug Administration (FDA) guidance on bioanalytical method validation, all provide good sources for ensuring formulation analysis is reliable and accurate.

In GLP toxicology analysis, it is vital to partner with a lab that sets itself and meets its high standards of Good Laboratory Practice that go above and beyond those required by regulators.