Step-wise implementation of Good laboratory practices(GLP)

The implementation of the OECD Principles of Good Laboratory Practice (GLP) represents a significant challenge to novice organizations. The aim of the document is to provide a
sequential framework for GLP implementation. Although there are many ways to achieve
GLP compliance, the steps recommended here are based upon the practical experience of scientists who have already implemented GLP.

1. Stepwise Implementation Of Good laboratory practices Mohamed Minas M 200522601017

2. Table of contents 01 3 Responsibility Quality Assurance Organization Facility 02 4

3. Table of contents 05 07 Establishment Archive of documentation Apparatus, Materials & Reagents Raw Data 06 08

4. O rganization 01.

5. Study Directors, Quality Assurance personnel, Archivist. Arrange General GLP training for all faculty. Management should nominate Establish an organisational schemes for the management. Set up the standard format for personall y identifiable information.

6. Organise personnel records for all personnel using agreed formats. Prepare a SOP for the firm, analyse it and reform for staff organi z ation charts and documents. Decide who will be responsible for managing your organi z ation's SOP system and set your system in a SOP and all new SOPs will be managed by the specified system. Establish archives and Write an SOP for the archiving process.

7. Responsibility 02.

8. Approval of protocol and study plans including amendments and access to the SOP Write a workflow SOPs for protocols Technical conduct of the study, thus supervisors should have the knowledge of the GLP principles Comply with the instruction of the SOPs and record the raw data and ensure Interpretation, analysis, documentation and reporting of the results. 2.1 2.2 2.3 2.4

9. 03 Facility

10. Agree on a system for identifying equipment and instruments among all interested parties and this procedure is implemented. Physically identify (tag) all equipments listed as per the system. List all the equipment and instruments and utilized within the research facility. Write a SOP in the equipment log book (lifecycle approach), its importance and use. Log books for each equipment should be there.

11. Determine which maintenance operations require external contracts and Sign contracts with contractors and contract should be documented. Equipment shall be adequately inspected, cleaned and maintained and procedure should be implemented and appoint a person for maintainance . Laboratories should be well ventilated, free of dust, drafts and extreme temperatures. Documented Inspection, cleaning, maintenance and calibration of apparatus. Identify major equipment that need to be officially qualified. Qualify the systems selected to qualify .

12. Quality Assurance Unit 04.

13. Set up a quality assurance unit Develop the QA program based on the three inspection methods and determine any deviation from the approval protocol and report to SD and management Train QAU staff in verification and inspection techniques

14. Apparatus ,Materials & Reagents 05

15. Reagents used in the operation should be specified in the SOPs. Set up rules and write SOPs for solution preparation, etc. Establish rules for identifying, handling & storing all reagent components 5. 1 5. 2 5. 3

16. 04. 06. Establishment

17. Set rules for acquiring, modifying & approval of raw data Define the raw data audit process in all operating units and develop SOPs for the verification and QC work

18. Raw Data 07

19. List all computer systems used throughout the organization Identify systems that need formal validation Prepare formal validation protocols for systems that need to be validated Perform validation tests as per validation protocols. 7. 1 7. 3 7.2 7. 4

20. Draft formal validation reports for approved systems Educate all personnel to operate computer systems they need Write SOPs for using and maintaining computer systems Formally “deploy” the system upon completion of validation and training Set rules for organizing access rights and passwords and write SOP for that process

21. Archive of documentation 08

22. Look at existing SOPs and list all remaining SOPs Create a guiding calendar for all current studies within the organization Create a timeline to complete these SOPs and Add authors' names and allow time for an appropriate revision before signing Carry out a second gap analysis to identify any remaining gaps in GLP compliance

23. Thank You !