Question

Your newly established facility was recognised by NATA as being compliant with the OECD Principles of GLP and your first GLP study is now well under way. It is a multi-site study. The in-life aspect of the study is being conducted by a Test Facility located in Switzerland. Rat plasma samples are being shipped to your GLP facility in Brisbane. However, troubles lie ahead. The person responsible for the analytical phase in your Brisbane facility has just informed you that she has resigned to take up another job elsewhere, effective immediately. After the initial shock you quickly regain your composure and start compiling a list of what now needs to occur in order for the analytical phase of the study to be successfully completed. Identify five (5) actions / processes that must occur in order for the study to remain compliant with the Principles of GLP. Each action / process should be described in one sentence.

Answer 1

Five actions /processes that must occur in order for the study to remainn compliant with the following measures like:

• apparatus and quality instruments used for testing the samples with the analysis of the physical, chemical and biological properties should be installed with appropriate quality and appropriate capacity.
• The health and sterilization facilities for the testing of animal and plant samples should be tested with appropriate measures.
• The test system equipment should be handled and installed carefully for the monitoring of the experimental conditions in the plant.
• The study of the diseases of animals on which experiments are being conducted in the pilot plant should be carried out with proper sterilization and sanitation and under a healthy environment.
• Handling, sampling and storing of the samples should be carefully done under proper conditions of temperature and pressure with proper installation of instruments and equipments. It should be according to the quality compliance standards.