The document outlines the principles and regulatory requirements of Good Laboratory Practices (GLP) essential for laboratory studies in pharmacognosy. It emphasizes the importance of data integrity, quality assurance, and proper organization of laboratory facilities and personnel. Additionally, it highlights the benefits of adhering to GLP, including improved company reputation and enhanced data analysis and record-keeping.
The document outlines the principles and regulatory requirements of Good Laboratory Practices (GLP) essential for laboratory studies in pharmacognosy. It emphasizes the importance of data integrity, quality assurance, and proper organization of laboratory facilities and personnel. Additionally, it highlights the benefits of adhering to GLP, including improved company reputation and enhanced data analysis and record-keeping.
The document outlines the principles and regulatory requirements of Good Laboratory Practices (GLP) essential for laboratory studies in pharmacognosy. It emphasizes the importance of data integrity, quality assurance, and proper organization of laboratory facilities and personnel. Additionally, it highlights the benefits of adhering to GLP, including improved company reputation and enhanced data analysis and record-keeping.
The document outlines the principles and regulatory requirements of Good Laboratory Practices (GLP) essential for laboratory studies in pharmacognosy. It emphasizes the importance of data integrity, quality assurance, and proper organization of laboratory facilities and personnel. Additionally, it highlights the benefits of adhering to GLP, including improved company reputation and enhanced data analysis and record-keeping.
GOOD LABORATORY PRACTICES Definition of GLP • GLP embodies a set of principles that provides a frame work within which laboratory studies are planned performed, monitored,archived and reported. Purpose of GLPs:
• GLP is tocertify thateverystep of the
analysis is valid or Not. • Assure thequality & integrity of data submitted to FDA in support of the safety of regulatedproducts. • GLPs have heavy emphasis on data recording, record & specimenretention. GOOD LABORATORY PRACTICES PRINCIPLES. 1. Test Facility Organisation and Personnel. 2. QualityAssuranceProgramme(QAP). 3. Facilities. 4. Apparatus, Material andReagents. 5. Test systems. 6. Test and ReferenceSubstances. 7. Standard Operating Procedures(SOP). 8. Performanceof The Study. 9. Reporting of Study Results. 10. Storage and Retention of Recordsandmaterials. Test Facility Organization and Personnel
Study Personnel Responsibilities
• Should have the Knowledgeof the GLP principles. • to the study plan and appropriate Access SOP’s. • Complywith the instructions of the SOP’s. • Record rawdata. Study • personnel are responsible for the quality of theirdata. • Exercise health precautions to minimize risk. • Ensure the integrityof thestudy. 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 determinecompliance of the studywith 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. Facilities
• Suitablesize, constructionand location.
• Adequate degreeof separationof the different activities. • Isolationof testsystemsand individual projects to protect from biological hazards. • Suitable rooms for the diagnosis, treatment and control of diseases. • Storage rooms. Apparatus, Materials and Reagents
• Apparatus of appropriate design and
adequatecapacity. • Documented Inspection, cleaning, maintenance and calibrationof apparatus. • Apparatusand materials not to interfere with the testsystems. • Chemicals, reagentand solutions should be labeled to indicate identity, expiry and specificstorage instructions. Test Systems
• Physical and chemical testsystems.
• Biological testsystems. • Records of source, date of arrival, and arrival conditions of test systems. • Proper identification of test systemsin their containerorwhen removed. • Cleaning and sanitization of containers. • Pest control agents to bedocumented. Test and Reference Items • Receipt, handling, sampling and storage • Characterization. • Known stability of test andreference items. • Stabilityof the test item in itsvehicle (container). • Experiments to determinestability in tank mixers used in the field studies. • Samplesfor analytical purposes for each batch. Standard Operating Procedures (SOP)
Written procedures for a laboratories
program. They define how tocarryout protocol- specified activities. Most often written in a chronological listing of actionsteps. They arewritten toexplain how the procedures aresuppose towork. SOP’s Routine inspection, cleaning, maintenance, testing and calibration. Actionsto be taken in responseto equipment failure. Keeping records, reporting,storage, mixing and retrieval of data. Definitionof raw data. Analytical methods. 8. Performance of the Study • Prepare the Study plan. • Contentof thestudyplan. › Identification of thestudy. › Records. › Dates. › Reference to testmethods. › Information concerning thesponsor and facility. • Conduct of the study. 9. Reporting of Study Results • Information on sponsorand test facility. • Experimental starting andcompletion dates. • A Quality Assurance ProgramStatement. • Description of materials and testmethods. • Results. • Storage (samples, reference items, raw data, final reports) etc. 10. Storage and Retentionof Records and Materials – Thestudy plan, rawdata, samples. – Inspection data and master schedules. – SOPs. – Maintenance and calibrationdata. – If anystudy material isdisposed of before expiry the reason to be justified anddocumented. – Index of materialsretained. What Good Laboratory Must Contain? • Area should be free from smoke, smell, dustetc. • Ensure good ventilation,proper Illumination. • Air conditioned the labwith humidity control. • Enough space for measuring and testing instrument. Cont…
• Proper arrangement of testing.
• Takecareof all safety points including proper earthing as well as firesafety. • Avoid uncleanablespots in floors, walls, ceiling. • Establish properareas for storage of incoming samplesas well as test–completed samples. • Also providesamplecollection placeas well as packing and disposal of tested samples. Do this for GLP • Keepthe things at its location afteruse. • Store heavy things at bottom & if possibleon Trollies. • Give nameof location toeverything. • Follow “Everything has the place & Everything at its place” principle. • Prepare location list & display it. • Put ladders forthings stored on top. • Identifyeverything with its name/ purpose. • Follow “FIFO” to prevent old accumulation for laboratory chemicals. Benefits of good laboratory practices. • It will givebetter image of companyas a Quality producer in Global market. • Provide hot tips on analysis of dataas well as measureuncertaintyandperfect record keeping. • Provide guidelines fordoing testingand measurementindetail. • Provideguidelines and bettercontrol for maintenance of instruments, environmentcontrol, preservationof testrecordsetc 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 measurementindetail. • Finally GLP Provide guidelines and better control for maintenance of instruments, environment control, preservationof test recordsetc.
