What Do We Mean by GLP?
Good laboratory practice (GLP) refers to a quality control system meticulously designed to ensure the integrity and reliability of studies performed in non-clinical laboratories. Hence, GLP acts as a guide that helps in key activities such as study planning, execution, monitoring, data collection, reporting, and archival. The key principles of GLP are as follows:
- Quality Assurance: Having a system in the GLP Lab that can oversee the entire study and flag issues related to GLP non-compliance.
- Standard Operating Procedure: Having a detailed step-by-step set of written instructions for all laboratory procedures. It helps ensure consistency in experimental methods, consequently leading to less variability in corresponding results.
- Comprehensive Documentation: It ensures that all aspects of the study are appropriately recorded in a GLP lab.
- Data Integrity: It refers to the maintenance of accuracy, reliability, and security of data related to experimental studies conducted in a GLP lab.
- Personnel Training: Good laboratory practices help ensure that personnel working in a GLP lab are appropriately trained to work on the studies assigned to them.
- Facilities and Equipment: The GLP system ensures that the facilities and equipment in a laboratory meet GLP requirements. E.g., calibration and maintenance of instruments.
- Study Design and Conduct: The aim and objectives of a study, the methods used, and the evaluation criteria must be clearly defined.
- Reporting: Data obtained from a study and results obtained from analysis must be correctly and entirely reported in a GLP lab to ensure the reliability of the study.
- Inspections: Regular inspections must be conducted within the laboratory facility to ensure that activities within the laboratory are GLP-compliant.
- Data Archival: All information related to the study should be suitably stored and archived for long-term access.
From the above-described GLP principles, it is evident that the primary goal of GLP is to ensure that non-clinical studies are conducted consistently and reliably so that the results obtained from them are also reliable and reproducible.
GLP in Scientific Research
Among non-clinical laboratories, GLP is crucial in fields such as pharmaceuticals, food and agrochemical products, cosmetics, and other regulated products because the results of their studies guide critical decision-making about the safety of products and their marketing approval. Some of the GLP bioanalysis studies conducted in good practice laboratories include physicochemical testing of drugs, pharmacodynamic studies, drug and environmental toxicity studies, pharmacology studies, mutagenicity and genotoxicity studies, and Copy Number Analysis. In addition to these drug-based studies, GLP principles also find importance in laboratories that conduct studies related to animal and plant metabolism, determining pesticide residues in food products and animal feed, environmental toxicity, effects of substances on complex ecosystems, and other analytical and clinical chemistry testing.
What are the Benefits of Working in a GLP Lab?
GLP helps create a structured environment with improved safety, minimizes errors and variability, and increases the accuracy, reliability, and reproducibility of data, thus enhancing the credibility of scientific research. Therefore, GLP is a cornerstone in scientific research, and working in a GLP lab provides experience in this environment. Since GLP is not just a set of guidelines but a fundamental aspect of scientific research, it also helps people to adopt ethical practices and moral values.
Having understood what GLP is and its importance in a laboratory conducting non-clinical studies, it is easy to guess that failure to comply with GLP can risk the disqualification of the laboratory. It means that the laboratory is not only barred from conducting new studies but also from submitting existing ones for regulatory approval. Thus, working in a good practice laboratory will help employees become aware of such issues and assist in minimizing non-compliance. Some of them include not always wearing personal protective equipment (PPE) inside the laboratory. Despite following all protocols, there is always a risk of an accident. PPEs help to protect personnel in the rare event of an accident. Another common issue is not using a control sample during an experiment. Although it might appear that data have been collected appropriately during an experiment, the use of controls helps to compare the test data with that of the control sample. It crucially determines whether the result obtained is genuine and whether the outcome of a failed experiment is not due to an error in data collection. Record-keeping is another area that commonly faces GLP non-compliance.
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Often, laboratory personnel involved in a study feel the urge to record all pertinent information at the end of the study. However, when doing so, many times, crucial information is often missed. Calibration of instruments is another aspect that laboratory personnel should be careful about. The use of uncalibrated instruments questions the reliability of the data collected and the experiment conducted. Refresher training and other on-the-job training, although they might seem redundant, help ensure that all personnel are trained for their work and are aware of issues related to safety, conduct, and responsibility. Hence, avoiding these sessions violates GLP regulations. Thus, working in a GLP lab is an invaluable opportunity in the field of scientific research.
