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ROI CalculatorGood Laboratory Practice (GLP) is a quality standard that guarantees organizations following best practices while performing various laboratory activities. GLP has been so far used in research studies directly related to the safety of medicines, chemicals, and devices for regulatory purposes.
The primary aim of GLP is to make sure that the study results can be confirmed, traced, and validated during inspections. Besides, GLP provides guidance on how to conduct studies, where to keep raw data, how to maintain equipment and staff qualifications.
The Good Laboratory Practice guidelines for different elements of a study are as follows:
Personnel: Before the study commences, the Testing Facility Manager will need to appoint a Study Director who will oversee the implementation of the study and ensure compliance with GLP regulations. There has to be an independent Quality Assurance Unit in the Testing Facility.
Facility & Equipment: Ensuring separation of roles in the Testing Facility is paramount in avoiding any form of obstruction from activities that can affect the outcome of the study. There must be separate areas for:
Any equipment utilized in the course of the study needs to be calibrated and maintained regularly. Records with respect to the calibration and maintenance of equipment shall be maintained and made available to the users of the equipment.
Study Plan or Protocol: Study protocol or study plan serves as the main directive document showing the general scheme of carrying out the study. Moreover, the study protocol contains the description of the method and materials utilized for the study.
When the study protocol has been approved by the study head, it has to be submitted to the Quality Assurance Unit for assessment of its compliance with the requirements of Good Laboratory Practice. Yet this is the stage of the procedure when the specialist should be told about their duties, mentioned in the study protocol and handed respective copies of this document.
Standard Operating Procedures: Every individual area within the testing facility should have Standard Operating Procedures (SOPs), especially for those procedures involving routine operation. Each SOP should be sanctioned or approved by the facility manager, and approval from the study director must be obtained if there is a need for deviations in the process.
Final Report: The study director has the responsibility of preparing as well as approving the final report. Key features of the final report are:
Storage of Records: During the entire process of the study, the study director will ensure that he/she captures all the information relating to the study and stores it safely in records. The storage of records or documentation such as SOPs, the study protocol, and final report will be done after completion of the study.
Retention of Records: The time to keep archive records is contingent upon the GLP laws in the country concerned. In the US, research labs should rely on the guide provided in Subpart J of 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies).
