GLP.pptx

Good Lab Practise

1. GOOD LABORATORY PRACTICES (GLP) Presented by: Jagriti Gupta Ishan Madan Afeefa Khan Hiba Haider B.Pharm 6 th Semester SFS. (Quality Assurance)

2. GLP : Good Laboratory Practices GLP is an FDA regulation. GLP embodies a set of principles that provides a framework within which a laboratory studies are planned ,performed ,monitored , reported & archived. GLP help assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be confidence upon when marking risk/safety management.

3. HISTORY OF GLP GLP is an FDA regulation,which was created in 1978. Although GLP originated in US,it has world wide impact. Non-US companies that wanted to do business with US or register their pharmacies in the US had to comply with the US GLP regulations. This lead to forming their own country GLP regulations. In 1981 OECD produced GLP principles that are international standard. GLP in OECD principles is defined as “a quality system concerned with the organizational process and the conditions under non-clinical health and environmental safety studies are planned, performed, monitored , recorded, archived & reported.”

4. Why was GLP created? In early 70’s FDA became aware of cases of poor laboratory practices in US. This lead FDA to undergo in-depth investigation of 40 toxicology labs,and they discovered a lot of fraudulent activities and poor laboratory practices being followed. Eg : 1.Equipment not been calibrated to standard form,which lead to incorrect measurements. 2.Inadequate test system.

5. FAMOUS EXAMPLE One of the labs that undergo such investigation made headline news.The name of the lab was Industrial Bio Test,it was big lab which conducted tests for companies like Procter & Gamble.It was discovered that the mice that they used for testing lotions and deodrants for human use developed cancer and died.The lab threw the mice and covered the results deeming to be good for human use.Later when this incident came to knowledge the personnels involved in production,distribution and sales for the lab eventually served jail time.

6. OBJECTIVES OF GLP GLP makes sure that the data submitted are a true reflection of the results obtained during the study. GLP make sure that the results are traceable. GLP promotes international acceptance of tests.

7. GENERAL PROVISIONS It prescribes GLP for conducting non-clinical laboratory studies that support research and marketing permits of product regulated by FDA. Applicability to studies performed under grants and contracts. Inspection of the testing facility.

8. ORGANISATION & PERSONNEL Organisation Personnel Testing Facility Management Study Director Quality Assurance Unit

9. ORGANISATION FUNCTIONS Identification of quality activities. Dividing the jobs among the personnel. Define the authority and responsibility of each job and relationship of each job with other jobs. Coordinate the work of internal departments and outside agencies.

10. PERSONNEL Each individual engaged in the conduct or supervision of non-clinical laboratory study shall have: Education Training General Training Specific Training Experience or Combination Personal sanitation & health precautions

11. TESTING FACILITY MANAGEMENT A sufficient number of qualified personnel,appropriate facilities,equipment and materials are available for conductance of study. Maintenance of records of qualifications , training and experience of personnel and their job description. Appointment of study director. QA program with designated personnel.

12. STUDY DIRECTOR A scientist or other professional of appropriate education,training and experience. Responsibilities- Approval of protocol & study plans including amendments. Technical conduct of the study. Ensure that the QA personnel & study personnel are updated with the study plan &SOPs. Interpretation,analysis,documentation and reporting of the result. Checks and verifies the experimental data recorded. Sign and date the final report for acceptance of data.

13. QUALITY ASSURANCE UNIT An individual or a group designated by management to assure that the studies are in compliance with GLP principles. Monitors the study to assure management that everything is in conformance to regulation. Maintain the copies of master schedule sheet,protocol and SOPs. Access to updated study plans and SOPs. Documented verification of compliance of the study with the GLP principles. Inspection to determine the compliance of study with GLP principles.

14. FACILITIES General facilities: Testing system facilities. Archive facilities. Waste disposal. Animal care facilities.

15. GENERAL FACILITIES Testing system facilities: Suitable size, construction and location. Adequate degree of separation of different activities. Laboratories should be well ventilated, free from dust , drafts and extreme T. Archive facilities: Secure storage and retrieval of study plans, raw data, final report and specimens to prevent untimely deterioration. Waste disposal: Appropriate collection , storage and disposal facilities and decontamination procedures.

16. ANIMAL CARE FACILITIES Located away from testing laboratories preferably in a separate building. Contamination risk is reduced by “barrier” system,as well as by providing clean and dirt free corridors. Separate for animals of different species and studies. Separate areas for diagnosis,treatment and control of laboratory animal diseases. Lightening should be proper as light intensity and noise level is sufficient. Maintain room T,humidity and air changes in animal quarters.

17. EQUIPMENT Appropriate design and adequate capacity. Equipment shall be adequately inspected , cleaned and maintained. Equipment used for generation , measurement or assessment of data shall be adequately tested , calibrated and standardized. Log books for each equipment should be there.

18. TESTING FACILITIES OPERATION A testing facility shall have standard operating procedures in writing setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. Organization chart: describes how the facility functions. Master Schedule: ensure that all studies, contracted or in-house, are included. CV and JD: A record of the qualifications, training, experience, and job description for each individual should be maintained. SOP’s: Appropriate and technically valid SOPs should be established and followed, and all original and revised SOPs should be approved Quality Assurance Unit: designated and adequately trained personnel should be established. The quality assurance responsibility should be performed in compliance to the principles of good laboratory practice.

19. TEST AND CONTROL ARTICLE Test article -means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections 351 and 354- 360F of the Public Health Service Act. Control article -means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any article other than a test article, feed, or water that is administered to the test system in the course of a nonclinical laboratory study for the purpose of establishing a basis

20. PROTOCOL FOR CONDUCT OF A NON CLINICAL LABORATORY STUDY The nonclinical laboratory study shall be conducted in accordance with the protocol. The test systems shall be monitored in conformity with the protocol. Specimens shall be identified by test system, study, nature, and date of collection. The FDA conducts careful inspections of facilities that perform nonclinical laboratory studies to determine compliance with Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) of Title 21 of the Code of Federal Regulations.

21. RECORDS AND REPORT A final report shall be prepared for each non-clinical laboratory study and shall include: 1.Name and address of the facility performing the study and the dates 2. Statistical methods employed for analyzing data. 3.The test and control articles identified by name, code number, strength, purity, and composition or other characteristics. 4. Stability of the test and control articles under the conditions of administration. 5.A description of the methods used. 6. A description of the test system used 7.A description of the dosage, dosage regimen, route of administration, and duration. 8.The name of the study director, other scientists, supervisory personnel involved in the study. 9. A description of the transformations, calculations, or operations performed on the data, a summary, and analysis of the data, and a statement of the conclusions drawn from the analysis.

22. 10. The locations where all specimens, raw data, and the final report are to be stored. 11.The statement prepared and signed by the quality assurance unit. 12.The final report shall be signed and dated by the study director. 13.Corrections or additions to a final report shall be in the form of an amendment by the study director.

23. STORAGE AND RETRIEVAL OF RECORDS AND DATA All raw data, documentation, protocols, final reports are generated as a result of a non-clinical laboratory study shall be retained. There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. An individual shall be identified as being responsible for the archives. Only authorized personnel shall enter the archives. Material retained or referred to in the archives shall be indexed to permit expedient retrieval.

24. DISQUALIFICATION OF A FACILITY Before a workplace can experience the consequences of noncompliance, an explanation of disqualification is needed. The FDA states the purpose of disqualification as the exclusion of a testing facility from completing laboratory studies or starting any new studies due to not following the standards of compliance set by the Good Laboratory Practice manual. Possible Violations can be- 1.Failure to prepare, retain, or submit written records required. 2.Falsifying information related to testing-protocols, ingredients, observations, data equipment, etc. 3. Falsifying information for a permit, registration or any required records.

25. THANK YOU!