Good Laboratory Practice. Quality Control and quality Assurance

Good Laboratory Practic

1. Mahatma Gandhi Vidhyalaya’s Pharmacy College, Panchavati Nashik. 422003 A seminar on Good Laboratory Practices Presented by- Ms. Yogita Vijay Ahire F. Y. M. Pharmacy Roll no- 34 Under the guidance of – Dr. K. V. Bhambar Department of Q.A MGVs pharmacy college Nashik 1

2. Content: Defination Introduction History Need Merits Principle MGVs pharmacy college Nashik 2

3. Defination of GLP: Good Laboratory Practice is a quality system concerned with the organizational process and the conditions under which a study is planned, performed, monitored, recorded, archived and reported. MGVs pharmacy college Nashik 3

4. Good Laboratory Practices: GLP applies to nonclinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals).
GLP helps assure regulatory authorities that the data submitted are a true. MGVs pharmacy college Nashik 4

5. History: The formal regulatory concept of “Good Laboratory Practice” (GLP) originated in the USA in the 1970’s.
The FDA’s publication of Proposed Regulations on GLP in 1976, with establishment of the Final Rule in June 1979 (21 CFR 58). In 1981 an organization named OECD produced GLP principles that are international standard. MGVs pharmacy college Nashik 5

6. Need of GLP: In the early 70’s FDA became aware of cases of (PLP) poor laboratory practice all over the United States.
FDA decided to do an in-depth investigation in 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices.
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 plan MGVs pharmacy college Nashik 6

7. Development of quality test data Remove many sources of error
Mutual acceptance of data
Avoid duplication of data
Avoid technical barriers to trade
Protection of human health and the environment Merits: MGVs pharmacy college Nashik 7

8. GLP stresses the importance of the following main points: Resources : Organization, personnel, facilities and equipment. Characterization : Test items and test systems. Rules : Protocols, standard operating procedures (SOPs) Results : Raw data, final report, and archives. Quality Assurance : Independent monitoring of research processes MGVs pharmacy college Nashik 8

9. Principle of GLP: Test facility organization and personnel Quality Assurance (QA) program
Facilities Apparatus materials and reagents
Test systems
Test and reference items
Standard Operating Procedures (SOP’s)
Performance of the study
Reporting of study results Storage and retention of records and materials MGVs pharmacy college Nashik 9

10. Test facility organization and personal Should have the Knowledge of the GLP principles.
Access to the study plan and appropriate
SOP’s.
Comply with the instructions of the SOP’s. Record raw data.
Study personnel are responsible for the quality of their data.
Exercise health precautions to minimize risk Ensure the integrity of the study. MGVs pharmacy college Nashik 10

11. 2. Quality Assurance Program Access to the updated study plans and SOP’s. Documented verification of the compliance of study
plan to the GLP principles.
Inspections to determine compliance of the study with
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. MGVs pharmacy college Nashik 11

12. 3. Facilities Suitable size, construction and location.
Adequate degree of separation of the different activities.
Isolation of test systems and individual projects to protect from biological hazards.
Suitable rooms for the diagnosis, treatment and control of diseases. Storage rooms. MGVs pharmacy college Nashik 12

13. 4. Apparatus, Material and reagents Apparatus of appropriate design and adequate capacity. Documented Inspection, cleaning,
maintenance and calibration of apparatus.
Apparatus and materials not to interfere with the test systems.
Chemicals, reagent and solutions should be labelled to indicate identity, expiry and specific storage instructions. MGVs pharmacy college Nashik 13

14. 5. Test systems Physical and chemical test systems
Records of source, date of arrival, and arrival conditions of test systems.
Proper identification of test systems in their container or when removed.
Cleaning and sanitization of containers. Pest control agents to be documented. MGVs pharmacy college Nashik 14

15. 6. Test and Reference items Receipt, handling, sampling and storage
Characterization.
Known stability of test and reference items.
Stability of the test item in its vehicle (container).
Experiments to determine stability in tank mixers used in the field studies.
Samples for analytical purposes for each batch. MGVs pharmacy college Nashik 15

16. 7. Standard operating procedure Procedures for a laboratories program.
Carry out protocol- specified activities.
To explain how the procedures are suppose to work. Routine inspection, cleaning, maintenance, testing and calibration
Actions to be taken in response to
Keeping records, reporting, storage,
mixing, and retrieval of data.
Analytical methods. MGVs pharmacy college Nashik 16

17. 8.Performance of study Prepare the Study plan.
Content of the study plan. > Identification of the study. > Records, dates.
> Reference to test methods. Conduct of the study. MGVs pharmacy college Nashik 17

18. 9. Reporting of study results Information on sponsor and test facility. Experimental starting and completion
dates.
A Quality Assurance Program Statement.
Description of materials and test methods. Results.
Storage (samples, reference items, raw data, final reports) etc. MGVs pharmacy college Nashik 18

19. 10. Storage and retention of Records and Materials The study plan, raw data, samples.
schedules.
SOPs.
Maintenance and calibration data
Before expiry the reason to be justified and documented. Index of materials retained MGVs pharmacy college Nashik 19

20. Benefits of GLP: Provide guideline for doing testing and measurement in detail. Provide guidelines and better control for maintenance of instruments, enviroment control, preservation of test records etc. It will give better image of company as a Quality producer in Global market MGVs pharmacy college Nashik 20

21. References: Text book of pharmaceutical Quality assurance. Nirali PrakashanBy Dr. Sohan Chitlange Dr. Rupali kale. Peg no. 9.1 to 9.14 Good Laboratory Practices – why and how Article By Asian Akyr on reserchget.net MGVs pharmacy college Nashik 21

22. . THANK YOU MGVs pharmacy college Nashik 22