Good laboratory practices, or GLP, are principles intended to assure the integrity and quality of non-clinical studies supporting research and marketing submissions to government agencies. GLP bioanalysis is often associated with drug development involving non-clinical animal testing conducted before assessing drugs in human subjects. However, GLP testing applies to other agents such as food packaging, food additives, medical devices, and color additives. 

The US FDA GLP lab regulations can be found in the 21 CFR 58 guidance. After analytical testing, such as LC-MS sample analysis in GLP studies, researchers often have confusion, leading to additional cost and work. Hence, the current article discusses good practices laboratory and trends for a modern laboratory. 

GLP testing

GLP only includes non-clinical studies. They do not apply to clinical assessments because clinical studies are governed by GCP regulations. Besides, much of the GLP bioanalytical structure depends on the study director, who is responsible for executing non-clinical studies. 

GLP testing is a quality management approach and not a scientific monitoring system. They define standards for data collection, study conduct, and experimental reporting. When researchers follow GLP guidelines, one can be sure that the generated results follow the study protocol. However, it fails to demonstrate whether the experiment answered the scientific hypothesis. 

The quality assurance unit is another critical component of GLP systems. This independent unit monitors GLP conduct, analysis, and reporting. They ensure that all procedures are conducted following written procedures. This quality control step instills confidence in the assay protocol but does not ensure high-quality results or analysis without any errors. However, GLP guidelines increase lab efficiency practices. 

Robust documentation is crucial for any research work. Earlier, GLP documentation was completed manually. This manual work led to errors. However, with the introduction of FDA 21 CFR part 11 guidance focusing on e-records and e-signature, most errors due to manual documentation have been minimized. Electronic storage helps maintain records and improves data handling, searching, and storage. Besides, electronic signatures prevent unauthorized use while improving laboratory practices and adequate documentation work. 

Today, analytical laboratories adopt multiple techniques and software for managing documentation and delivering good-quality results. However, with an ever-evolving regulatory landscape, enforcement and inspection practices are dynamic. Hence, adequate focus is needed for data security, integrity, and traceability of electronic records. 

Process automation systems are a breakthrough in bioanalytical laboratories. Today, bioanalytical laboratories employ automatic systems to conduct normal and simple laboratory work and advance accuracy and quality in data collection and management. Besides, integrating computerized techniques such as data processing, interpretation, storage, reporting, and maintenance is completely automated. However, employing computerized techniques needs to be adequately developed, validated, maintained, and operated in a manner compliant with GLP regulations. 

The study director is responsible for recording data electronically and ensuring it is the same as recorded on paper. He must maintain and protect computerized data from misinterpretation and loss by preventing unauthorized changes and access to experimental data.

In Conclusion

GLP guidelines have undergone drastic changes, including recent trends in e-records, laboratory automation, computerized systems, and software-based approaches like master control.