Commonly employed in nonclinical and preclinical research studies, the GLP studies are defined as a quality control system aimed at managing research and laboratory development methods. FDA believes that a GLP lab works with higher consistency, reproducibility, integrity, consistency, reliability, and produces efficient quality results for nonclinical safety tests, physiochemical studies, and toxicity profiling.
What is GLP?
Good Laboratory Practises or GLP studies are standards governing the laboratory studies to be designed, implemented, and recorded. According to the norms of the FDA, these studies form an essential part of the drug regulation process as the results generated here are accurate and reliable, thereby facilitating the experimentation to be reproduced accordingly.
The main objective of the GLP studies is establishing a set of principles, thereby supplementing a framework for a quality efficient organizational process and conditions to accomplish the laboratory process.
According to the OECD guidelines, the GLP practice is defined as “A quality system concerning with the organizational process and the applicable conditions under which both the environmental and nonclinical health studies are planned, monitored, performed, recorded, archived, and finally reported.”
Essential elements of the GLP studies or GLP strategy –
Qualification of testing facility management and personnel
Quality assurance program
Standard operating procedure
Performance of the research and reporting of the results
Qualification of the facilities
Qualification and validation of apparatus
Test systems, test items, and reference items
GLP guidelines work on a central feature of documentation along with maintenance of specimen records, chain of custody, raw or processed analytical data, instrument validation results, and analytical certification. The critical importance of the GLP procedure is the accountability of their laboratory results. Moreover, the GLP regulations work systematically to provide results which are reliable, reproducible, auditable, and accomplished through recognized drug testing protocols.
GLP or the goods laboratory practises is a quality management system and not a representative of any scientific management system. GLP sets a strict set of quality standards for conducting studies, collecting data, and reporting results.
Gaining practical knowledge about GLP is a pre-requisite in the present scenario as it guarantees both the work efficiency and better productivity.
What principles define good laboratory practice?
The good laboratory practices are defined by the following principles –
These are actual working practices rather than defining major works representing any artistic fiction. Thus, all the GLP studies follow a limited set of written instructions and principles.
GLP study regulations address all the essential responsibilities for the management of people, facility, and good equipment science.
Defines the correct intention for the installation and use of equipment and computer systems, thereby facilitating them to operate according to the desired specifications.
They are potentially used for reconstructing the entire protocol, generating the results throughout toxicological testing and profiling. It also facilitates verification and authentication.
