What Are The Fundamental Principles of GLP?

Good laboratory practices (GLP) are quality system concerning the organizational process and conditions which provide directions for the non-clinical health and environmental safety studies. These principles are crucial for all the test facilities accomplishing the studies necessary for submitting their application to the regulatory authorities. 

Objectives of GLP principles – 

The objectives of the good laboratory practice principles are as follows – 

• It ensures that the data submitted accurately represent the GLP laboratory results obtained during the study. 
• It ensures that the data is traceable. 
• It promotes international acceptance of the GLP certified tests. 

What is the purpose of accomplishing GLP studies?

The purpose of the GLP studies are – 

• Promoting the quality of the test data 
• Obtaining reliable and reproducible data 
• Obtaining comparable data between countries 
• Achieving international confidence in studying data 
• Optimizing animal conditions 
• Shortening the registration time of the pharmaceutical drug 

Principles of the GLP studies – 

The GLP studies’ principles are intended towards the identification of the GLP requirements for test facilities performing the studies according to the regulatory process. Such principles work on the concerned quality system and conditions that define planning, performance, monitoring, recording, reporting, and archiving the final test results. GLP concerns with the test data quality, thereby managing quality studies. 

The GLP principles were initially written down to address the animal-based toxicology issues. These are basically intended to assess the pharmaceutical, veterinary, and cosmetic products for their non-clinical efficacy. 

Test Facility Organization – 

The test facility organization of the glp laboratories are defined by the sufficient number of personnel working there, record maintenance and documentation, availability of training, appropriate and technical validation of the SOP, etc. 

The director of the test facility organization is responsible for – 

• Conducting the overall study and preparing its final results 
• Approval of the GLP study plan and subsequent amendments, if required
• Complete documentation of the raw data and its validation 

The principal investigator should ensure that the delegated phases of the GLP laboratory studies are conducted following the applicable GLP principles. 

Quality Assurance –

Any individual or the group designated as the management for assuring that the GLP studies are conducted following the GLP principles is known as quality assurance. It helps monitor the management facilities, equipment, methods, practices, records, and controls in firm confirmation with the GLP regulations. The quality assurance cell is responsible for documenting the verified report of the ongoing study with the GLP principles. 

Responsibilities of the quality assurance personnel – 

The quality assurance principle should assure for the following – 

• Maintenance of the master schedule copies, protocols, and SOP sheets, etc
• Accessing both the updated study plans and SOPs
• Conducting inspections concerning the study, facility, and process. 

Test and Reference Items – 

The guidelines for the excellent laboratory practices should account for the following details about the test and reference items – 

• Receipt, sampling, handling, and storage 
• Characterization concerning its code, batch number, purity, composition, and concentrations. 

SOPs – 

Standard operation procedures are the written documents specifying procedures for managing the laboratory programs. 

These procedures ensure both the quality and integrity of the data being generated. 

Any deviations from the SOP concerning the study protocol should be immediately documented.