Good Laboratory Practices

Good Laboratory Practices, Protocol, Contents of protocol, Conduct of a non-clinical laboratory study, Reporting of non-clinical laboratory study results,

1. Sumtted by : Neha 1784550032 Assignment :-1st Topic :- Protocol for & conduct of a Non-clinical laboratory study Submitted to: Mohammad khalid (Assistant Professor)

2. GLP(Good Laboratory Practice) GLP is a FDA regulation. GLP is a quality system concerned with the organizational process and the condition under which non-clinical health and environmental safety studies are planned , performed , monitered , recorded archived and reported. GLP is a formal regulation that was created by the FDA ( United States food and drug administration) in 1978 8 April 2020 Krishna Pharmacy College, Bijnor 2

3. Continue…… Good laboratory practice embodies a set of principle that provides a frame work within which laboratory studies are the planned , monitored , archived and performed. 8 April 2020 Krishna Pharmacy College, Bijnor 3

4. Protocol Each study shall have an approved written protocol that clearly indicates the objectives and all method for the conduct of the study. 8 April 2020 Krishna Pharmacy College, Bijnor 4

5. Contents of protocol Identification Title and statement of purpose Identification of test items Names and address of the sponsor , test facility and test site. Proposed date 8 April 2020 Krishna Pharmacy College, Bijnor 5

6. Continue……. Name of study director and other personnel. Justification for selection of the test system. Description of the test system. Experimental design 8 April 2020 Krishna Pharmacy College, Bijnor 6

7. Conduct of a non-clinical laboratory study The non-clinical laboratory study shall be conducted in accordance with the protocol. Information of the specimens should be present on container to avoid error in recording and storage of data. 8 April 2020 Krishna Pharmacy College, Bijnor 7

8. Continue……… All the data generated shall be recorded directly. Promptly and legibly by ink. 8 April 2020 Krishna Pharmacy College, Bijnor 8

9. Reporting of non-clinical laboratory study results A final report shall be prepared for the each nonclinical laboratory study. Information on sponsor and test facility. Experimental starting and completion dates. 8 April 2020 Krishna Pharmacy College, Bijnor 9

10. Continue…….. Objectives and procedure stated in protocol ( including the changes in protocol). Description or material and the test methods. A quality assurance program statement. Storage ( specimens, reference, items, raw data and final report ). 8 April 2020 Krishna Pharmacy College, Bijnor 10

11. Thank You…. 8 April 2020 Krishna Pharmacy College, Bijnor 11