Good laboratory practices

the principle and protocol of good laboratory practices

1. GOOD LABORATORY PRACTICES PRESENTED BY ANU K THANKACHAN 1 ST M. PHARM PHARMACEUTICAL ANALYSIS ST JAMES COLLEGE OF pharmaceutical sciences

2. GLP: 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. GLP 2

3. What is GLP? 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 . GLP 3

4. WHY WAS GLP CREATED? GLP 4 In the early 70’s FDA became aware of cases of poor laboratory practice all over the United States. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were Equipment not been calibrated to standard form , therefore giving wrong measurements. Incorrect/inaccurate accounts of the actual lab study. Inadequate test systems.

5. Purpose of GLPs: GLP 5 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 .

6. Scope of GLP Principles of GLP apply to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or licensing - Pharmaceuticals Pesticides Food and feed additives Cosmetic products Veterinary drug products and similar products Industrial chemicals GLP 6

7. Objectives of GLP GLP 7 True reflection Ensure Honesty International acceptance 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

8. GLP 8 Protocols of GLP

9. GLP 9 Organisation & Personnel – Management’s Responsibilities Ensure sufficient number of qualified personnel, appropriate facilities, equipment, and materials Ensure the maintenance of a record of the qualifications, training, experience. Proper training of personnel to assigned functions Job description for each professional and technical individual. To establish and follow SOP Quality assurance program with designated personnel

10. GLP 10 Organisation & Personnel – Study Director’s responsibilities Approval of protocols & the study plan including amendments Ensure QA personnel and study personnel are updated with study plans & SOP Ensure the follow up of SOPs periodically and take appropriate corrective action Archiving Raw data, supporting materials and final report.

11. GLP 11 Organisation & Personnel Ensures the study is conducted in accordance with GLP Recording of all raw data in compliance with the principles of GLP Deviations from the instructions to be reported the PI or SD Takes health precautions and personal safety Study Personnel’s Responsibilities Principal Investigator’s Responsibilities

12. GLP 12 Quality Assurance Programme Maintains copies of protocols & SOPs Inspects each laboratories and man at work – Study-based inspections Facility-based inspections Process- based inspections Determines any deviation from approved protocol and report to SD, PI & management Prepare a statements to be included in final report containing dates & types of inspection An individual or a group designated by management to assure studies are in compliance with GLP Principles

13. Facilities Test System Facilities Sufficient amount of rooms and areas to assure isolation of test systems Adequately protected storage area separate from test systems Areas available for the diagnosis, treatment and control of diseases GLP 13

14. Cont ……. Archive facilities Secure storage and retrieval of study plans, raw data, final reports & specimen to prevent deterioration Waste Disposal Appropriate collection, storage & disposal facilities and decontamination procedures GLP 14

15. GLP 15 Apparatus, Materials & Reagents Apparatus, including validated computerised systems should be of appropriate design & adequate capacity Chemicals, reagents and solutions should be labelled to indicate identity, DOE & storage instructions Apparatus to be periodically inspected, cleaned , maintained, and calibrated according to Standard Operating Procedures. Should not interfere adversely with the test systems.

16. 5. Test Systems GLP 16 Physical/ Chemical Biological

17. 6. Test and Reference Items GLP 17 Receipt, handling, sampling and storage Characterization. Known stability of test and reference items. Stability of the test item in its vehicle (container ). Samples for analytical purposes for each batch

18. 7.Standard Operating Procedures (SOP) GLP 18 1. Test facility should have a written SOP approved by management 2. SOPs should be available wherever applicable e.g. Test and reference items Apparatus, materials and reagents Record keeping, reporting, storage and retrieval Test system Quality assurance procedures 3.Any deviations from SOP should be documented & acknowledged by SD and PI

19. GLP 19 Performance of The Study For each study, a written plan – Approved by SD, management, sponsor Verified for GLP compliance by QAU If required, national regulation Contents of Study Plan Identification of the study , the test and reference item Information - sponsor and the test facility, SD, PI Test methods – reference to OECD/other test guidelines Issues – justification of selection Records

20. GLP 20 Reporting of study Results Information Identification Dates Statement Result Description Materials Location of study plans, specimens, data store

21. GLP 21 Storage & Retention of Records The study plan, raw data, samples of test and reference items, specimens and the final report of each study. Records of all inspections by QAP Records of qualifications, training, experience and job descriptions of personnel. Records and reports of the maintenance and calibration of apparatus. Historical files of all SOP

22. GLP 22 GLP in our country

23. National GLP-compliance Monitoring Authority was established by the Department of Science & Technology Approval of the Union Cabinet on April 24, 2002 GLP 23

24. Scope of GLP application to NGCMA (India) Physical-chemical testing Toxicity studies Mutagenicity studies Environmental toxicity studies on aquatic and terrestrial organisms Studies on behaviour in water, soil and air, bio-accumulation Studies on effects on natural ecosystems Analytical and chemical testing GLP 24

25. GLP 25 GLP-compliance Certification (valid for a 3 years) GLP Certification process

26. GLP 26 GLP Application form & certificate

27. Are we ready for GLP? GLP 27 when we do what we write when we write what we do We will achieve GLP …

28. REFERENCE NARENDRA PRADAP SING SENGER. PHARMACEUTICAL ANALYSIS III. P 48 - 52 SANDY WEINBERG. GOOD LABORATORY PRACTICES REGULATION. 4 th ed . p 131 - 150 http/Wikipedia.org/ GLP GLP 28 G.E . Paget, Good Laboratory Practice MTP Press Limited, Lancaster 1979 . p 56 - 65

29. GLP 29