GLP RULES

The study director will prepare a written study plan that meets GLP requirements. The GLP study plan will be audited by the QAU to ensure that the study plan meets the GLP requirements. Prior to study initiation the study plan must be reviewed and signed by the sponsor. The study director will ensure that a copy of the study plan any amendments are submitted to the sponsor and the original (signed) plan, amendments, and deviations, and exact copies will be submitted to the QAU for verification and will be retain the study file for further archiving.

 Every GLP study must be approved by the Institutional Animal Ethics Committee and the information on approval must correlate with the approved study plan. During the conduct of GLP studies, any determination of differences between SOPs and the study plan will be resolved on the basis that the approved study plan and SOPs.

You can have a study plan template for writing the GLP study plan. The template can be modified to suit to requirements of GLP study in question. Sometimes sponsor may prefer to use a different template for his/her study plan in which case QAU will audit the template to ensure that it adheres to OECD GLP principles and required SOPs.

GLP Study Plan must contain the following information at a minimum:

1.     A descriptive title and statement of purpose

2.     Identification of the test and control items by name, chemical abstract number, or code number

3.     The name and address of the sponsor and the name and address of the test facility

4.     The name and addresses of any sub-contract sites where study activities will be performed

5.     The number, body weight range, sex, source of supply, species, strain, sub-strain, and age of the test system

6.     The procedure for identification of the test system

7.     A description of the experimental design, including methods for the control of bias

8.     A description and/or identification of the diet to be used as well as solvents, emulsifiers, and/or materials used to solubilise or suspend the test or control items before mixing with the carrier.

9.     The type and frequency of tests, analyses, and measurements to be made

10. A description of the necropsy procedure, tissue collection, histological processing, and histopathological analyses to be performed

11. Instructions for handling moribund or terminal animals prior to study completion

12. The records to be maintained and the retention location

13. The dated signatures of the study director and the sponsor

14. A statement of the proposed statistical methods to be used and acceptable levels of statistical significance

15. Specify responsibility for performance of characterisation of test and control items including appropriate testing for identity, strength, purity, composition or other characteristics for each batch or lot and methods of synthesis, fabrication, or derivation of the test and control items and stability testing as applicable

16. If the study is conducted at multiple sites the location of the lead QAU will be included along with the names of principal investigators and/or contributing scientists. A flowchart, table, or narrative description of the roles and responsibilities and flow of communication for each site is recommended.

17. Specify that reserve samples of each batch or lot of test and control items will be retained for studies longer than 4 weeks in duration and the location where reserve samples will be retained

18. The location where raw data and specimens will be retained including residual tissues not used for histological analyses

19. A regulatory compliance section stating the GLP status of the study and any, consensus documents, and guidance documents that must be adhered to.

20. Define reporting requirements e.g., interim reports and contributing scientists’ reports

21. Method for documenting deviations and amendments to the study plan

Amendments to GLP study plan will be promptly prepared. Amendments must be approved by the study sponsor and exact copies provided to the QAU. Personnel providing support services for GLP studies will review study plan prior to study initiation and amendments prior to performing activities associated with the amendment. The reviews will be documented. Deviations to study plan and SOPs will be documented with justification. Prior approval for deviations to the study plan must be obtained from the study director whenever feasible. When prior approval is not possible, the study director will be promptly notified of deviations.