GLP
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GLP (Good Laboratory Practice) is a set of principles established by the FDA in 1978 to ensure the quality and integrity of safety data submitted for regulatory purposes. Key aspects of GLP include standardized facilities, equipment, test systems, operating procedures, personnel responsibilities, and record keeping. Studies must follow detailed study plans and SOPs. Quality assurance programs verify compliance. Proper storage and retention of raw data, samples, and reports is also required under GLP guidelines.
GLP
- 1. GLP: GOOD LABORATORY PRACTICE AMAL GEORGE MSc BIOCHEMISTRY
- 2. GLP • GLP is an FDA regulation. • GLP is a formal regulation that was created by the FDA (United states food and drug administration) in 1978. • Definition of GLP • GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored, and archived and reported.
- 3. HISTORY GLP was first introduced in New Zealand in 1972. GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. Industrial Bio Test Labs (IBT) was the most notable case, where thousands of safety tests for chemical manufacturers were falsely claimed to have been performed or were so poor.
- 4. Purpose of GLPs: • GLP is to certify that every step of the analysis is valid or Not. • Assure the quality & integrity of data submitted to FDA in support of the safety of regulated products. • GLPs have heavy emphasis on data recording, record & specimen retention.
- 5. GOOD LABORATORY PRACTICES 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.
- 6. 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.
- 7. 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. • Inspection of the final reports for accurate and full description. • Report the inspection results to the management. • Statements.
- 8. 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.
- 9. 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.
- 10. 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.
- 11. 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 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.
- 13. 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.
- 14. 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.
- 15. 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.
- 16. 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.
- 17. 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. • Follow “FIFO” to prevent old accumulation for laboratory chemicals.
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