GOOD LABORATORY PRACTICES

good laboratory practices (GLP) NOTES FOR STUDENT

1. ADVANCE COLLEGE OF PHARMACY Kanpur DEPARTMENT OF PHARMACOLOGY Mr. ANUBHAV DUBEY M.Pharma pharmacology GLP Presented- By

2. GOOD LABORATORY PRATICES 1.Introduction 2.History 3.OECD principles 4.GLP at glance 5.GLP in India

3. Introduction

4. Good Laboratory Practice (GLP) is a quality 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. Drugs-Companies Laboratories Government and Company Hazard assesment International trade. GLP DATA

5. Non-clinical health and environmental safety studies Experiments Not in a hospital Human beings Enviromnment

6. HISTORY

7. The word GLP- Newzealand 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 Lab (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 . 1972 1976

8. 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.

9. Famous example: In the early 70’s FDA became aware of cases of poor laboratory practice all over the US. 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 Their findings were: Equipment not been calibrated to standard form , therefore giving wrong measurements. Incorrect/inaccurate accounts of the actual lab study. Inadequate test systems.

10. One investigation- made headline news The name of the Lab was Industrial Bio Test. Ran tests for big companies- 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 deeming the products good for human consumption.Those involved in production,distribution and sales for the lab eventually served jail time. IBT

11. GLP was instituted in US following cases of fraud generated by toxicology labs in data submitted to the FDA by pharmaceutical companies. As a result of these findings, FDA promulgated the Good Laboratory Practice (GLP) Regulations, 21 CFR part 58, on December 22, 1978 (43 FR 59986). The regulations became effective June 1979 .

12. As a international standard: In 1981 an organization named OECD (organization for economic co-operation and development ) produced GLP principles that are international standard . of 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.

13. USA FDA OECD INTERNATIONAL LEVEL COUNTRY LEVEL ORIGINATOR FOR THE GLP INSTITUITIONS -GLP

14. 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 not to indulge in any fraud activity by labs. Promotes international acceptance of tests. OBJECTIVES

15. GOOD LABORATORY PRACTICE PRINCIPLES

16. 1.Test Facility Organisation and Personnel 2. Quality Assurance Programme 3. Facilities 4. Apparatus, Material, and Reagents 5. Test Systems 6. Test and Reference Items 7 . Performance of the Study 8 . Reporting of Study Results 9 . Storage and Retention of Records and Materials GOOD LABORATORY PRACTICE - PRINCIPLES

17. 1.Test Facility Organisation and Personnel Test Facility Management’s Responsibilities Study Director’s Responsibilities Principal Investigator’s Responsibilities Study Personnel’s Responsibilities

18. A.Test Facility Management’s Responsibilities. Responsibilities of management as defined by these principles of good laboratory practice. Sufficient number of qualified personnel, appropriate facilities, equipment , and materials are available for the timely and proper conduct of the Study Ensure the maintenance of a record of the qualifications, training, experience. Job description for each professional and technical individual. Documented approval of the study plan by the Study Director.

19. B.Study Director’s Responsibilities. approve the study plan. Any amendments to the study plan by dated Signature. Availability of SOPS to the personnel. Raw data generated are fully documented and recorded. Computerised systems used in the study have been validated. Sign and date the final report to indicate acceptance of responsibility for the validity of the data. Ensure that after completion (including termination) of the study, the study plan,the final report, raw data and supporting material are archived.

20. C.Principal Investigator’s Responsibilities The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice

21. 2.Quality Assurance Programme

22. 3. Facilities 1.Test s ystem facilities Sufficient number of rooms or areas assure the isolation of test systems and the isolation of individual projects involving substances or organisms known to be or suspected of being biohazardous. There should be storage rooms or areas as needed for supplies and equipment. Areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.

23. Archive Facilities Archive facilities should be provided for the secure storage and retrieval of study plans , raw data , final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration . Handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities , and decontamination and transportation procedures waste disposal

24. 4 . Apparatus, Material, and Reagents Apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study. Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures . Apparatus and materials used in a study should not interfere adversely with the test systems. Chemicals, reagents, and solutions should be labelled to indicate identity ( with concentration if appropriate), expiry date and specific storage instructions. Information concerning source, preparation date and stability should be available. The expiry date may be extended on the basis of documented evaluation or analysis.

25. 5&6.Test Items and test systems and characterisation

26. Drugs manufactured in the MNC s BioTestingLaboratory Send to the labs for quality assurance and also testing for the toxicity aganist to the mammals. and environment. 2.Characterization: Test item-product going to be tested –composition, stability, chemical nature solubility, new formula or modified previous product formula, identity, potency, impurity profile , Test system-to which animal is going to be administere Results submitted to the FDA-US Government and OECD (International standards). Further release into the market and reproduction.

27. 7 .Performance of the Study Study Plan Content of the Study Plan Dates Test Methods Issues (where applicable) Records. A list of records to be retained. Conduct of the Study.

28. 8 .Reporting of Study Results Content of the Final Report Identification of the Study, the Test Item and Reference Item Information Concerning the Sponsor and the Test Facility Dates Statement Description of Materials and Test Methods Results Storage

29. 9 . Storage and Retention of Records and Materials The study plan, raw data, samples of test and reference items, specimens and the final report of each study. Records of all inspections performed by the Quality Assurance Programme, as well as master schedules. Records of qualifications, training, experience and job descriptions of personnel. Records and reports of the maintenance and calibration of apparatus. Validation documentation for computerised systems.

30. GLP AT A GLANCE

31. Product manufacturing Testing laboratories Non clinical and environmental safety studies 1.Test Facility Organisation and Personnel 2. Quality Assurance Programme 3. Facilities 4. Apparatus, Material, and Reagents 5. Test Systems 6. Test and Reference Items 7 . Performance of the Studynon 8 . Reporting of Study Results 9 . Storage and Retention of Records and Materials. Data submission to the regulated authorities - Government ,FDA SAFETY NON SAFETY Relesed into the market OECD PRINCIPLES OF GLP INTERNATIONAL TRADE

32. GLP IN OUR COUNTRY INDIA

33. National GLP-compliance Monitoring Authority was established by the Department of Science & Technology approval of the Union Cabinet on April 24, 2002 A provisional member of the OECD for GLP. India is an Observer to the OECD’s Working Group on GLP The Authority has trained 33 experts in the country as GLP inspectors.

34. GLP-COMPLIANCE CERTIFICATION The test facilities/laboratories have to apply in the prescribed application form GLP-compliance Certification is valid for a period of three years The report, prepared by the inspection team, is put to the Technical Committee for recommendation to Chairman, National GLP- Compliance Monitoring Authority After the application for GLP certification is received, a pre-inspection of the laboratory is carried out by the GLP inspectors, followed by a final inspection.

35. Dr D R Prasada Raju   Head /Scientist G [email protected] National GLP Compliance Monitoring Authority Department of Science and Technology Technology Bhawan , New Mehrauli Road, New Delhi-110 016 (Telefax 011-26510686) Mrs Ekta Kapoor Scientist D Department of Science and Technology Technology Bhawan , New Mehrauli Road, New Delhi-110 016 (Phone: [phone]) E-mail: - [email protected]   HEAD OF NGCMA:

36. Our aim : is to be get the status of full membership in the near future so that the Indian industries do not have to get their test facility (products) certified from safety angle by other GLP monitoring authorities and do not lose on the trade front.

37. Conclusion GLP is an FDA regulation which is accepted and approved as international standards by OECD to avoid the fraud activities of the testing laboratories for pesticides , pharmaceuticals , food additives , dyes, to save the human and environmental health and also erect good international trade and establish good relationship among the countries .

38. Thank you