Good laboratory practices (GLP)

Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion

1. GOOD LABORATORY PRACTICES BY : DIVYA BHARDWAJ MSc. FMT SEM 3 RD ROLL NO. 110077

2. GLP : Good Laboratory Practices In the experimental (non-clinical) research area , the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability , reproducibility , quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests .

3. LP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial Bio Test Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries. “Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived”.

4. REASON BEHIND THE CREATION OF GLP : In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. FDA decided to do an in-depth investigation on 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were 1 . Equipment not been calibrated to standard form , therefore giving wrong measurements. 2 . Incorrect/inaccurate accounts of the actual lab study 3 . Inadequate test systems

5. One of the labs that went under such an investigation made headline news. The name of the Lab was Industrial Bio Test . This was a big lab that ran tests for big companies such as Procter and Gamble (P & G). It was discovered that mice that they had used to test cosmetics such as lotion and deodorants had developed cancer and died. Industrial Bio Test lab threw the dead mice and covered results deeming the products good for human consumption. Those involved in production, distribution and sales for the lab eventually served jail time.

6. OBJECTIVES OF GLP GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study. GLP also makes sure that data is traceable. Promotes international acceptance of tests.

7. THE OECD The OECD Council, data generated in the testing of chemicals in one OECD Member Country, in accordance with OECD Test Guidelines and the Principles of GLP are accepted in all other OECD Member Countries. GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are : - planned , - performed , - monitored, - recorded, - archived and - reported.

8. GLP PRINCIPLES 1. Test Facility Organisation and Personnel. 2 . Quality Assurance Programme(QAP). 3 . Facilities. 4 . Apparatus, Material and Reagents. 5 . Test systems. 6 . Test and Reference Substances. 7 . Standard Operating Procedures(SOP). 8 . Performance of The Study. 9 . Reporting of Study Results. 10 . Storage and Retention of Records and materials.

9. 1. TEST FACILITY ORGANIZATIONAL AND PERSONNEL Should have the Knowledge of the GLP principles. Access to the study plan and appropriate SOP’s. Comply with the instructions of the SOP’s. Record raw data. Study personnel are responsible for the quality of their data. Exercise health precautions to minimize risk. Ensure the integrity of the study.

10. 2. QUALITY ASSURANCE PROGRAMME Access to the updated study plans and SOP’s. Documented verification of the compliance of study plan to the GLP principles. Inspections to determine compliance of the study with GLP principles. Three types of inspection. – Study-based inspections. – Facility-based inspections. – Process-based inspections. Inspection of the final reports for accurate and full description. Report the inspection results to the management. Statements .

11. 3. FACILITIES Suitable size, construction and location. Adequate degree of separation of the different activities. Isolation of test systems and individual projects to protect from biological hazards. Suitable rooms for the diagnosis, treatment and control of diseases. Storage rooms.

12. 4. APPARATUS , MATERIALS AND REAGENTS Apparatus of appropriate design and adequate capacity. Documented Inspection, cleaning, maintenance and calibration of apparatus. Apparatus and materials not to interfere with the test systems. Chemicals , reagent and solutions should be labelled to indicate identity, expiry and specific storage instructions.

13. 5. TEST SYSTEMS Physical and chemical test systems. Biological test systems. Records of source, date of arrival, and arrival conditions of test systems. Proper identification of test systems in their container or when removed. Cleaning and sanitization of containers. Pest control agents to be documented.

14. 6. TEST AND REFERNCE ITEMS Receipt, handling, sampling and storage Characterization . Known stability of test and reference items. Stability of the test item in its vehicle (container). Experiments to determine stability in tank mixers used in the field studies. Samples for analytical purposes for each batch.

15. 7. STANDARD OPERATING PROCEDURES (SOPs) Written procedures for a laboratories program. They define how to carry out protocol- specified activities. Most often written in a chronological listing of action steps. They are written to explain how the procedures are suppose to work. Routine inspection, cleaning, maintenance, testing and calibration. Actions to be taken in response to equipment failure. Keeping records, reporting, storage, mixing, and retrieval of data. Definition of raw data. Analytical methods.

16. 8. PERFORMANCE OF THE STUDY Prepare the Study plan. Content of the study plan. › Identification of the study . › Records. › Dates. › Reference to test methods. › Information concerning the sponsor and facility. Conduct of the study.

17. 9. REPORTING OF THE STUDY RESULTS Information on sponsor and test facility. Experimental starting and completion dates. A Quality Assurance Program Statement. Description of materials and test methods. Results . Storage (samples, reference items, raw data, final reports) etc.

18. 10. STORAGE AND RETENTION OF RECORDS AND MATERIALS The study plan, raw data, samples. Inspection data and master schedules. SOPs . Maintenance and calibration data. If any study material is disposed of before expiry the reason to be justified and documented. Index of materials retained.

19. WHAT GOOD LABORATORY MUST CONTAIN ? Area should be free from smoke, smell, dust etc. Ensure good ventilation, proper illumination and prefer natural light. Air conditioned the lab with humidity control. Enough space for measuring and testing instrument. Proper arrangement of testing. Take care of all safety points including proper earthing as well as fire safety. Avoid uncleanable spots in floors, walls, ceiling. Establish proper areas for storage of incoming samples as well as test–completed samples. Also provide sample collection place as well as packing and disposal of tested samples.

20. DO THIS FOR GLP Keep the things at its location after use. Store heavy things at bottom & if possible on Trollies. Give name of location to everything. Follow “Everything has the place & Everything at its place” principle. Prepare location list & display it. Put ladders for things stored on top. Identify everything with its name/ purpose.

21. BENEFITS OF GOOD LABORATORY PRACTICES It will give better image of company as a Quality producer in Global market. Provide hot tips on analysis of data as well as measure uncertainty and perfect record keeping. Provide guideline for doing testing and measurement in detail. Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc.

22. CONCLUSION Gives better image of company as a Quality producer in Global market Provide hot tips on analysis of data as well as measure uncertainty and perfect record keeping & guideline for doing testing and measurement in detail. Finally GLP Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc.

23. THANK YOU