GLP studies for method development - Tentamus Group (2024)

The focus of the Tentamus Group's GLP studies includes:

• Product chemistry tests according to FAO, WER, OECD, US-EPA OCSPP
• Animal and plant metabolism studies on the life and analysis of fish bioaccumulation and feeding studies
• Environmental impact studies
• Residue and multi-residue analysis (MRA)
• Validation of residue methods, ILV
• Residue and efficacy studies
• Bioanalytical services
• In-life studies on crustaceans (shrimps, crabs) & sample analysis
• Preclinical pharmaceutical capabilities
• Evaluation of the volatilization of dicamba products using quantitative humidome tests
• Toxicological/ecotoxicological studies on birds
• Formulation stability study
• Field studies
• Nutrient, anti-nutrient and allergen analyses
• Nutritional-physiological equivalence studies
• Molecular biology (PCR, qPCR, Southern blot, ELISA, Western blot, SGF, and SIF assays)
• Studies on displaceable residues on the leaf (DFR)
• CE-MS of polar charged species - e.g. proteins, peptides, small charged & polar challenged molecules in various tissues (biological formulations, plant samples, pharmaceuticals, etc.)

GLP studies on product chemistry

As part of Good Laboratory Practice (GLP), various types of product chemistry studies can be performed in our testing facilities. Here are some examples:

• 5-batch analyses: these studies involve the analysis of five consecutive production batches to ensure that product quality and stability remain consistent during production. It is therefore an efficient quality assurance system.
• Physical/chemical characterization: These studies involve the determination of physical and chemical properties of a product, including density, viscosity, pH, solubility, melting point and flash point.
• Validation of enforcement methods: These studies involve the validation of methods for the quantitative analysis of active ingredients and impurities in products. The methods are validated to ensure that they are accurate and precise and comply with Good Laboratory Practice (GLP) principles.
• Stability studies: These studies involve evaluating the stability of a product over a period of time under different storage conditions. The studies are used for quality assurance. The stability and shelf life of the product is evaluated to ensure that it remains safe and effective during its shelf life.
• Analysis of impurities: These studies involve analyzing impurities in a product to ensure that they are within approved limits and have no undesirable effects on the safety or efficacy of the product.
• Residue and contamination studies: These studies involve the evaluation of residues and contaminants in products, including pesticides, herbicides, fungicides and other chemicals. The studies are used to test the safety of the product. The aim is to ensure that the residues and contaminants are below the permitted limits and have no undesirable effects on the safety or efficacy of the product.

These studies are used for quality assurance and ensure that products are safe and effective, comply with the Chemicals Act (ChemG) and meet the principles of good laboratory practice.

GLP validation

GLP validations include the verification and documentation of the producer's analytical methods, devices and instruments. It is checked whether the process complies with the principles of good laboratory practice, whether the equipment functions correctly and whether the analytical methods used deliver the desired results. This process includes the development of precise protocols, the performance of tests and experiments, safety checks as well as the review of data and the preparation of reports.

GLP validations are required in many areas of the laboratory diagnostics and pharmaceutical industries, including preclinical and clinical research, drug development, drug production and quality control. They are often required by regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to ensure the quality, reliability and integrity of laboratory data.

GLP validations may include various parameters that can vary depending on the type of analytical methods, equipment or instruments. In general, however, GLP validations typically include the following parameters:

1. Accuracy: Accuracy refers to the ability of an analytical method or instrument to provide results that are close to the true or certified reference values. Accuracy is often assessed by comparing test results to known reference materials or reference methods.
2. Precision: Precision refers to the reproducibility and repeatability of results when the same analysis or measurement is performed repeatedly under similar conditions. Precision is usually assessed by determining repeatability and reproducibility measurements.
3. Linearity: Linearity refers to the ability of an analytical method or instrument to exhibit a linear relationship between the amount of analyte analyzed and the measured signal concentration. Linearity is often evaluated by generating calibration curves with different concentrations of analyte.
4. Range: The range refers to the range of concentrations or values over which an analytical method or instrument can provide accurate and reliable results. The range is usually evaluated by performing tests with different analyte concentrations.
5. Limit of detection (LOD) and limit of quantification (LOQ): The LOD is the lowest concentration of an analyte that can be detected by a particular method or instrument, while the LOQ is the lowest concentration that can be quantitatively determined. The LOD and LOQ are often determined by analyzing samples with low analyte concentrations and calculating corresponding signal criteria.
6. Robustness: Robustness refers to the ability of an analytical method or instrument to provide accurate results despite small variations in experimental conditions, such as changes in temperature, humidity or run time. Robustness is usually assessed by specific variations in experimental conditions.
7. System suitability: System suitability refers to the ability of an instrument or system to repeatedly provide accurate and reliable results. This is often assessed by checking system parameters such as background noise, system stability and other specific requirements of the analytical method.

It is important to note that the exact requirements for validation of analytical methods, devices or instruments according to GLP principles and applicable regulations and standards may vary and depend on the type of analysis, industry and regulatory requirements.

In GLP (Good Laboratory Practice) studies, various analytical methods are used at the test facility to ensure the integrity, quality and validity of test results. Some of the common methods are:

1. Chromatography techniques: HPLC (high-performance liquid chromatography), GC (gas chromatography), LC-MS (liquid chromatography-mass spectrometry) and GC-MS (gas chromatography-mass spectrometry).
2. Spectroscopic techniques: UV-VIS spectroscopy (ultraviolet-visible spectroscopy), FTIR (Fourier transform infrared spectroscopy) and NMR (nuclear magnetic resonance spectroscopy).
3. Microscopic and imaging techniques: electron microscopy, light microscopy, scanning electron microscopy (SEM) and transmission electron microscopy (TEM).
4. Physico-chemical analysis methods: viscosity, density, pH value, surface tension, refractive index, melting point and boiling point.

• These methods are used in the characterization of test substances, the performance of stability studies and the analysis of samples during experiments. The use of validated analytical methods is an essential part of good laboratory practice and ensures the accuracy, reliability and repeatability of test results.

A GLP procedure correction is a change to a documented procedure used following Good Laboratory Practice (GLP) standards for performing nonclinical tests on chemicals and other substances.

If a deviation or error is discovered in a procedure, a procedure correction may be required to correct the procedure and ensure that it meets the requirements of the GLP standards. A procedure correction may be a change to a document, work instruction, protocol or other part of the procedure.

A procedure correction should always be documented and dated so that the time of the correction can be traced. In addition, all affected employees should be informed of the procedure correction and trained to ensure that the corrected procedure is followed correctly.

GLP procedure corrections are important to ensure that the experiments performed meet the highest quality standards and that the integrity of the data is guaranteed.

The Tentamus Group laboratories work strictly in accordance with GLP specifications and are approved for GLP studies and analyses. This includes among others:

• Category 1
  Tests to determine physicochemical properties and content determinations
• Category 6
  Tests for the determination of residues
• Category 8
  Analytical tests on biological materials

The Tentamus Group can support companies in implementing the GLP (Good Laboratory Practice) standards in various ways. Here are some of the ways:

1. Consulting and training: Tentamus Group offers consulting services to help companies implement GLP guidelines. The team of experts can provide training to improve staff understanding of GLP standards and ensure procedures and processes are compliant.
2. Laboratory testing: Tentamus Group can assist companies in the selection of GLP-compliant laboratories capable of performing the required non-clinical testing on chemicals and other substances. The Group has a network of laboratories in various countries that specialize in different areas.
3. Conducting GLP studies: The Tentamus Group can support companies in conducting GLP studies. The Group has its own GLP-certified laboratories and can also work with other laboratories to perform tests that meet GLP standards.

By helping companies implement the GLP standard, Tentamus Group can help to improve the quality and reliability of non-clinical testing of chemicals and other substances and increase confidence in the results.