GLP or Good Laboratory Practice is defined as a quality control system that is concerned with both the process and conditions of the organization where both the environmental safety and non-clinical health studies are planned, executed, and accomplished. In fact, GLP is a set of principles that are intended towards assuring both the quality and integrity of all the analytical testing and non-clinical laboratories involved.
Non-Clinical Good Laboratory Practice
This type of non-clinical studies also refers to experimental research where a quality system controls the management and testing protocols of a laboratory where the actual research is taking place. The main aim of the GLP lab is to generate consistent, reliable, uniform, and quality intact non-clinical safety study results. Furthermore, it ensures that the results generated from these studies are both of high consistency and reproducibility.
The Intent of GLP Lab Practice
The gap service laboratory provides a framework for performing well-controlled studies for –
- Assuring both quality and integrity of the study data
- Facilitating reconstruction of the study design
- Providing overall accountability
A well-equipped GLP lab according to the following –
GLP lab strictly adheres to well-planned and carefully executed studies for delivering the most useful and relevant information to the reviewers seating there in the FDA chairs. They robustly adhere to comply with all the essential elements towards achieving their GLP lab compliance goals.
Approach for Good Laboratory Practice
GLP complying labs are process-oriented and are dedicated to providing quality data for proper utilization and control over facilities, personnel, and all the relevant procedures. They operate in flexible mode and make the best use of scientific judgment.
GLP Surveillance Inspections
Most of the GLP labs facilitate both periodic and routine evaluations about the general capability for conducting GLP compliant studies.
Emphasizes on Quality Assurance Program
The test facility or the excellent laboratory practice testing center ensures a well-documented approach for every single research and development that is being carried out in the lab there. The quality assurance program of such laboratories comprises maintaining proper copies of all the SOPs and approved study plans to be used in the testing facility.
These labs are designed to be of a suitable size, constructed to minimize any form of disturbance that might interact with study validity. There should be a proper demarcation of the facility made available so that every single study could be accomplished appropriately.
Apparatus, Materials, and Reagents
Glp laboratories should firmly adhere to the calibration and validation protocols for their instruments, reagents, equipment, and materials being used. All these are regularly inspected, cleaned, calibrated, and maintained according to the pre-defined norms of the Standard Operating Protocols. Moreover, they rely on the written standard operating procedures approved by an authorized test facility system. This is to ensure top-notch quality and integrity of the data generated. An advantage of working with GLP-compliant labs is that they are recorded and maintain any deviations noticed from the Standard Operating Procedures that are applied throughout the drug discovery process.
Get real time update about this post categories directly on your device, subscribe now.