Good lab practices

general detail of good lab practices...

1. GOOD LABORATORY PRACTICES PRESENTED BY- REENA TOMER Ph.D Scolar of panjab university

2. GOOD LABORATORY PRACTICES Acc. To OECD principles, GLP is “a q uality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are: Planned Performed Monitored Recorded Archived and Reported The purpose is not to assess the intrinsic scientific value of a study

3. In the early 1970s, the FDA investigated a number of cases of poor practice in toxicology laboratories throughout the USA The FDA decided to perform an in-depth investigation in 40 toxicology laboratories . FDA discovered fraud cases during investigation. Inadequate characterization of test items and test systems Inadequate resources Equipments were not properly calibrated. Reports were not sufficiently verified, inaccurate a ccount of study or raw data Inadequate archives and retrieval processes How GLP was introduced?

4. Example In Industrial Bio Test lab , it was discovered that mice that they had used to test cosmetics such as lotion and deodorants had developed cancer and died 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.

5. Resources: Organization, personnel, facilities and equipment Characterization: test items and test systems Rules: Study plan and Standard operating procedures (SOP). Results: Raw data, final report and archives Quality Assurance: Audit/Inspection, Training , Advice FUNDAMENTAL POINTS OF GLP

6. Resources M anagement and personnel Management must take overall responsibility for both the conduct and interpretation of the study , including all scientific and organizational aspects GLP also stresses that there should be sufficient staff to perform the tasks required. The qualifications and the training of staff must also be defined and documented. Facilities and equipment The regulations emphasize the need for sufficient facilities and equipment to perform the studies. All equipment must be in working order. To ensure this, a strict programme of qualification, calibration and maintenance must be adopted

7. 2 . Characterization We should have prior and proper knowledge about the test item (pharmaceutical item) the test system (often an animal or plant) to which the test item is to be administered

8. Protocols and written procedures The institute’s rules for organizing and conducting GLP studies must be defined in documents approved by management. Rules defining who does what, how, when and where, are called PRESCRIPTIVE documents. the protocol (or study plan) which describes how the study is designed and how it is to be conducted, including the expected timeframe of the study; • the standard operating procedures (SOP) which provide detailed instructions about how to actually perform each technical procedure, and how to ensure sound organization of the study, its environment and data. 3. Rules

9. Raw data All studies generate raw data. These are the outcome of research and form the basis for establishing scientific interpretations and arriving at conclusions. The raw data must also reflect the procedures and conditions of the study. Final Report The study report contains the detailed information that how the study was performed, incorporate the study results and also include the scientific interpretation of the data. The report is provided to regulatory authorities as part of the submission for registration and marketing approval. Archives Storage of records must ensure safekeeping for many years and allow for prompt retrieval . 4. Results

10. 1Quality assurance personnel Quality assurance (QA), as defined by GLP, is a team of persons charged with assuring management that GLP compliance has been attained within the laboratory. QA must be independent from scientists involved in the operational aspects of the study being performed. QA functions as a witness to the whole non-clinical research process . 2.Study plan contains the information-verification 3.Conduct inspections Study-based inspections Facility-based inspections Process-based inspections . 4.Records of such inspections should be retained 5. Quality Assurance

11. GLP promotes the quality and validity of the test data. a tool for management of laboratory studies. PURPOSE OF GLP

12. To help scientists obtain results that are: • Reliable. • Repeatable. • Auditable. • Recognized by scientists worldwide. MISSION OF GLP

13. BENEFITS OF GLP Reduce the number of false negatives. (A false negative means a set of results that falsely reports that a test item is not toxic when in reality it is toxic.) Assures that the data are a true reflection of their results obtained from studies Promotes international recognition of study data. Limiting waste of resources Ensuring high quality of study data. Validity of test data.

14. General Laboratory Rules Each person in the lab should maintain a hardbound laboratory notebook with continuously numbered pages as a permanent record of his work and ideas Do not crowd the entries. Do not delete, over write or erase, instead cross out Do not remove pages from notebook

15. Lab should be cleaned properly. Adequate space. Ventilation. Hygiene. Periodic fumigation. All chemicals should be labeled. Switch off the power while leaving. Remove slippers before entering lab .

16. The work area should be cleaned and maintained in a sanitary condition. • Surfaces or equipment where work with biological materials is conducted should be routinely decontaminated. Laboratories must have a sink for hand washing

17. All manipulations of infectious materials within the laboratory must be conducted in the biological safety cabinet. BIOSAFETY CABINETS

18. Chemicals and Reagents handling

19. Know the hazards of each chemical before using. Never use Flammable chemicals (diethyl ether, acetone, triethylamine ) in lab that has an open flame anywhere in the room. Be careful not to spill any flammable solvent on a heating mantle or hot plate. Always clean up spills immediately. Corrosives like hydrochloric acid, sulphuric acid should be handled with great care so as not to spill them or inhale their vapors and wear the protective gear. Contd..

20. Equipment handling Maintenance and regular inspection of laboratory equipment are essential parts of this activity. Many of the accidents that occur in the laboratory can be attributed to improper use or maintenance of laboratory equipment Equipment shall be adequately inspected, cleaned and maintained Scales & balances should be calibrated at regular intervals (usually ranging from 1-12 months).

21. Glassware cleaning Cleaning agents - detergent solution - chromic acid - distilled water A brief soaking in warm detergent is usually sufficient to remove the grease and dirt responsible for causing the water breaks where detergent is not effective, rinse glassware with concentrated acids. Use detergents or conc. HCl for cleaning hard rubber and plastic bottles. After the glassware and bottles have been cleaned, rinse thoroughly with reagent water.

22. STERILIZATION Complete destruction of the pathogenic organism. Autoclaving is the sterilization method commonly used in research laboratories and hospitals. It involves heating in a chamber with saturated steam under heavy pressure so that the chamber temperature rises to at least 121˚C for a minimum of 15 minutes. All material being autoclaved must be in contact with steam and heat for complete sterilization. Dry heat may also be used, though it is less effective and takes longer durations and very high temperatures.

23. WEIGHING Fundamental requirement for all analyses • Accuracy of balances • Care in operation - protection from corrosion - cleaning after every use vibration free table When using digital weighing balance, switch off the fans. In case of weighing volatile or corrosive substances, take aluminum foil or butter paper.

24. PERSONAL PROTECTION

25. Face protection Face protection is a safety device such as a face mask and face shield to protect the face from injury or exposure to biological agents.

26. Fire extinguishers, Fire blankets, Fire alarms, First aid kit, Eye washes and showers. Fire prevention and fire protection

27. Storage of infectious material Potentially infectious materials must be placed in a durable, leak proof container during collection handling, processing storage transport.

28. Animal handling Housing - Sufficient, hygenic and ventilated space. - Cleaning and sanitation of cages, Racks and accessory equipment at appropriate intervals Feeding -Feed and water shall be analyzed periodically to ensure that contaminants known to be capable of interfering with study. Waste disposal -Facilities shall exist for the collection and disposal of all animal waste and refuse

29. Waste disposal Immediate treatment and disposal are ideal procedures to be followed for disposal of biomedical waste. Untreated biomedical waste however, can be stored for not more than 48 hrs. If for some reason it becomes necessary to store the waste beyond such period, permission from the local state authority must be taken and it must be ensured that it does not adversely affect human health and the environment.

30. SEGREGATION OF WASTE RED BAG OR CONTANIER Plastic waste IV Sets, Tubings Blood & Urine bags Syringes No Sharps INFECTIOUS WASTE Soiled bandages Dressings, Cotton Swabs Sanitary Pads No plastics YELLOW BAG OR CONTAINER

31. Im portance of Recording of Experimental Data Essential for protecting one’s intellectual property. Determining ownership of ideas. Validation of results to support grants and manuscripts. Allow others to reproduce one’s work.

32. Guidelines for good clinical laboratory practices (GCLP) by ICMR, 2008. Research methodology by N.Gurumani The National Academies: Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards: Updated Version, 2011 http://www.who.int/tdr/publications/documents/glp-trainer.pdf References

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