GLP (Good Laboratory Practices)

this ppt covers all the quary about the GLP

1. TOPIC:- GOOD LABORATORY PRACTICE Prepared by :- Vijay Banwala

2. GOOD LABORATORY PRACTICE

3. In the early 70’s FDA became aware of cases of poor laboratory practice all over the U S. They discovered many fraudulent activities and a lot of poor lab practices. Examples of some poor lab practices are : Equipment do not calibrated to standard form, therefore giving wrong measurement. GLP was first introduced in New Zealand and Denmark in 1972 , and then in US in 1978 in response to Industrial Bio Test Labs scandal.

4. T h erapeu tic concept Target validat i on Lead f i nding Target se lec t i o n Lead optim i z at i on Preclinical develop m ent Clinical develop m ent Regulatory approval P r oduct Discovery Developm e nt Drug Discovery and Development Process

5. Good Laboratory Practice (GLP) GLP is a regulation created by USFDA and these regulations w as proposed on November 19,1976 and designated as a new part of Chapter 21 of the Code of Federal Regulations(CFR) as 21 CFR Part 58 in 1979. GLP in OECD principles is defined as “a quality system concerned with the organizational process and the conditions in which non-clinical health and environmental safety studies was planned, performed, monitored, recorded, archived and reported”.

6. GLP :- GLPs was initially invoked in a reaction to malpractices in the laboratories conducting safety experiments of medicines. In the early 1970s,research laboratories in the USA found doing work in unethical ways : - Data generation without conduct of the study. Replacement of dead animal and fabrication of test result.

7. Advantages of GLP :- Assures that the data in true reflection of result obtained from studies. :- Preclinical safety and residue safety. :- Generation of high quality test data. :- Mutual acceptance of data :- Increases public confidence. :- Shortens the time-to-market for new products. Disadvantages of GLP :- More man power is required. :- Expensive process.

8. Objectives of GLP 1.) GLP makes sure that the data submitted was true reflection of the results obtained from the stud y. 2.) GLP make sure that the data is traceable. 3.) Promotes international acceptance of test.

9. GLP Principles Testing facility organ i za t ion and personnel Storage and retention of records and materials Repor t i n g of study results Quality as s u r a n ce program F ac i lities Ap p a r atus, materials ,reagents Test sy s t e ms Test and reference s u bstances Standard operating procedures P e r f ormance of study

10. How to practice GLP? General provisions Organization and Personnel Facilities Equipment Testing facilities operation Test and control articles Protocol for and the conduct of the study Records and Reports

11. A. General provisions It prescribes GLP for conducting non-clinical laboratory studies that support research and m ar k eting per m its of produ c ts regulated by FDA. Applicability to studies performed under grants and contracts. Inspection of the testing facility.

12. B. Organization and Personnel Organization Personnel Testing facility management Study director Quality assurance unit

13. C. Facilities 1) General facilities: Testing system facilities Archive facilities Waste disposal 2) Animal care facilities

14. D . Equipment 1.) Appropriate design and adequate capacity. 2.)Equipment used for generation, measurement or assessment of data shall be adequately tested, calibrated and standardized. 3.)Log books for each equipment should be there.

15. E. Testing Facilities Operation Standard operating procedures(SOPs) Reagents and solutions Animal care

16. F. Test and Control Articles Test and control article characterization Test and control article handling Mixture of articles with carriers

17. G. Protocol for and conduct of a nonclinical laboratory study Protocol Conduct of a nonclinical study

18. Storage, retrieval and retention of records and data :- Archives should be there for orderly storage and expedient of all raw data, documentation, protocols, specimens and final reports. Index of material retained. Mas ter sc h edule sheet, copies of pro t oc o ls and records of Quality Assurance inspections shall be maintained by QAU. Wet specimens and samples of test and control articles shall be retained until the quality of preparation affords evaluation .