Introduction of GLP:
Table of Contents
GLP was introduced for non-clinical safety studies in 1976. In the late 90s, this practice and OECD (Organization for Economic Co-operation and Development) were accepted as the industry standard. GLP has been introduced due to the poor and dishonest practice in a laboratory in the early 70s. The poor lab practices include the wrong calibration of equipments, inaccurate test systems, and accounts. In 1983, the Industrial Bio-Test Laboratory (1952-1978) of New York was found guilty as it provided wrong and inaccurate research data to the Government. The company provided fake, fabricated, and concealed data of the tests on rodents involving Trichlorobanilide (deodorant soap additives), Naprosyn (arthritis drug), Sencor (Herbicide), and Nemacur (Pesticide).
According to Valcarcel M., GLP is a set of rules, operating procedures, and practices established by an organization to ensure quality and accurate results in laboratory practice. In this practice, the given organization sets the principles, and the laboratory works are planned, operated, overlooked, and reported.
Fundamentals of GLP
Resources It includes the following:
1. Organization and Management: Management has the overall responsibility for the implementation of both good science and good organization within their institutions. Good science includes a proper definition of experimental design, knowledge of scientific principles, documentation of experimental and environmental variables, complete evaluation of the results, and reporting of results. Whereas, a good organization should provide proper planning of studies, qualified skilled personnel, adequate facilities, infrastructures, proper conduction of studies, and verification process for the study results.
2. Personnel: The detailed records should be maintained for every individual staff of the institution. The records include the detailed curriculum vitae, training records, and job descriptions. These records should meet the GLP requirements and these are maintained to establish that every staff has the competence, education, experience, and training to perform the tests.
3. Availability of Facilities: Adequate facilities with state-of-the-art infrastructure should be provided by the institution and management to ensure the validation of the studies. The cleaning, maintenance, and documents of the site plan should satisfy the guidelines.
4. Availability of Equipments: Adequate equipments must be available for the study in the organization. The suitability of the equipment and calibrated instruments should be provided by the management.
Characterization It includes:
1. Test Items: It may be an active ingredient for medicine, a pesticide, a food additive, a vaccine, an industrially used chemical, biomass, or extraction from plants. These items are characterized by analytical profiles like chemical identification tests, solubility, stability, etc. The test items should be stored properly to avoid contamination.
2. Test Systems: The test systems could be animals, bacteria, cells, organs, and plants. Sometimes they may be analytical equipments also. The test systems should be handled in such a way that they must comply with the GLP guidelines and with the national animal welfare law.
1. Study Protocols: The study plan or protocol describes how the study is designed and how it is to be conducted. The plan should include the expected timeframe of the study.
2. Written Procedures: Written procedures are often known as SOPs (Standard Operating Procedures). SOPs provide the instructions on how each technical procedure should be performed, how to ensure the sound organization of the study, environmental variables, and data.
Results It includes raw data, final reports, and data archiving.
1. Raw Data: The original record and the data needed for the reconstruction should be recorded. The raw data should include ‘what’ was done, ‘how’ it was done, when the work was done, and who performed the work. The recorded data should clarify the process by which it is generated and should confirm the process has been performed as per the guidelines and SOPs.
2. Final Results: Final results are the responsibility of the study director. These results should describe the study accurately and the scientific interpretation. The results should reflect accurately the raw data. The review and audit of these reports should be done. All accepted changes in the results approved by the reviewer should be incorporated before the finalization of the results.
3. Archives: Archiving is a safe depositing of all information. It is considered to be a center for the compilation and distribution of summary documents. The archiving of documents helps the reconstruction of studies performed earlier.
Quality assurance requires to validate the experimental results. Quality assurance unit (QAU) or simply QA must review all phases of preclinical research, organization framework, staff documents, study procedures, and SOPs. The internal audits and inspections should be performed by the QA officers. The QA performs the study-based audit, facility, and systems-based inspection, and process-based inspections.
GLP principles are a set of organizational requirements. GLP is a regulation covering the quality management of non-clinical safety studies. The regulation aims to encourage scientists to organize and perform their studies in a way that promotes the quality and validity of the test data. GLP deals with the following issues:
- The facility is provided by the organization.
- Efficient and trained personnel.
- Quality of validated equipment and reagents.
- Predetermined study design.
- SOPs, process validation, and test procedures.
- Correctness of the results.
- Quality assurance laboratory (QAL) and Quality assurance program (QAP).
- Recorded and documented results and their storage.
The organizations should fulfill all the criteria to provide all the facilities for good laboratory practice. The personnel should have enough knowledge about the principles and working of the practices. In the elements of GLP, SOP is an important part of quality assurance. To maintain the productivity of the result, a well-documented SOP is required; moreover, the person should have complete information mentioned in SOPs. SOPs define the complete process flow and work steps that help to achieve accurate and precise results. Validated modern equipments and adequate facilities should be provided by the organization to maintain good practice in the laboratory. The complete specifications and storage of reagents and materials should be provided. A laboratory should have the proper test procedures (physical, chemical, and biological) and characterized data for both the test and reference materials. The quality assurance unit (QAU) bears the responsibility to assure the Good Laboratory Practice and this unit is attached with QAL and QAP. The audit of the laboratory and verification of the quality parameters are the major responsibilities of the QAU. The reported study results should be stored and retained in a well-documented manner.
Aim of GLP
1. GLP helps to reduce the number of false negatives arising from the studies. False-negative results for a toxicity study falsely intimated that the test item is not toxic, but in reality, the item is toxic.
2. GLP also helps to reduce the chance of false positives. In the case of a non-clinical safety study, the results wrongly predict that the test item is toxic when it is not.
3. GLP promotes international recognition of study data. When studies are performed according to OECD GLP principles, then the acceptability and reliability of the data are recognized at the international level by the OECD member states.
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