OCED-Principles of Good Laboratory Practices
- 1. SCHOOL OF MEDICALAND ALLIED SCIENCE Topic OECD- Principles of Good Laboratory Practices Arpan Pathak M. Pharma (Pharmacology) SMAS KR Mangalam University Sohan, Gurugram, India. Subject: Pharmacological & Toxicological Screening Model II Subject Code: MPL 202T
- 2. GOOD LABORATORY PRACTICE GLP is an FDA regulation GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978. The malpractice includes cases of fraud, lack of proper management and organization of studies performed to generate data for regulatory bodies. The US Food and Drug Administration mounted a series of investigation in toxicology laboratories throughout the USA. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of the chemicals.
- 3. Definition of GLP GLP is an FDA regulation. Good Laboratory Practice is defined in the OECD (1997) Principles as “a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, recorded, archived and reported. History GLP is a formal regulation that was created by the FDA in 1978. Although GLP originated in the United States, it had a world wide impact. Non-US companies that wanted to do business with the United Sates or register their pharmacies in the United States had to comply with the United States GLP regulations. They eventually started making GLP regulations in their home countries IN 1981 an organization named OECD (organization for economic co- operation and development) produced GLP principles that are international standard
- 4. WHY WAS GLP CREATED? In the early 70’s FDA became aware of the cases of poor laboratory practice all over the United States FDA decided to do an in-depth investigation 40 toxicology lab. Examples of some these poor lab practices found were Equipment not calibrated to standard form, therefore giving wrong measurement. Incorrect/inaccurate accounts of the actual lab study Inadequate test systems
- 5. Famous Example 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 rat tests for big companies such as Procter and Gamble. 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 deerling the products good for human consumption. Those involved in production, distribution and sales for the lab eventually served jail time.
- 7. GOOD LABORATORY PRACTICES PRINCIPLES
- 8. 1) Test Facility Organization and Personnel:- Study Personnel Responsibilities 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.
- 9. 2) Quality Assurance Program Responsibilities of the QA Personnel 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
- 10. 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. 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 labeled to indicate identity, expiry and specific storage instructions.
- 11. 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. 6) Test and Reference 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.
- 12. 7) Standard Operating Procedures(SOP):- • 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 supposed 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. 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. 9) Reporting of 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.
- 13. 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. 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. • 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. What is Good Laboratory? Proper Arrangement of Testing
- 14. 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. Reduce time spent on non-revenue earning investigation. Increased overall productivity.
- 15. CONCLUSION • Finaly GLP Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc.
- 16. References Good Laboratory Practice. By European Chemical Industry Ecology and Toxicology Centre (ECETOC), MonographNo. 1,Brussels October 1979 Good Laboratory Practice. by G.E. Paget, MTP Press Limited, Lancaster 1979.