This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya).

1. www.GlobalHealthLaboratories.org This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download, adapt, and distribute this presentation under the conditions that: the Global Health Laboratories and The Global Health Network are referenced; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions.

2. STANDARD OPERATING PROCEDURES KEMRI-Wellcome Trust Research Programme

3. SOP Definition • Standard Operating Procedures- documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines • Detailed, written instructions to achieve uniformity of the performance of a specific function- ICH GCP E6 1.5.5 KEMRI-Wellcome Trust Research Programme Ken Awuondo

4. Functions of SOPs • Establish standard procedures which will ensure quality and integrity of the data • To leave a permanent record of the methodology employed • To communicate these procedures to those who will undertake them and underpin training • SOPs are the way in which we set standards KEMRI-Wellcome Trust Research Programme Ken Awuondo

5. SOP Requirement • Management: • Ensure appropriate SOPs are established • Approve all original and revised SOPs • Ensure maintenance of historic file of all SOPs • Current versions available and Amendments documented • Should contain sufficient detail to provide clear instruction to staff KEMRI-Wellcome Trust Research Programme Ken Awuondo

6. SOP Requirement • Personnel: • Have access to appropriate SOPs • Responsible for complying with SOPs instructions • Communicate and document to responsible person any deviation from SOP instruction KEMRI-Wellcome Trust Research Programme Ken Awuondo

7. SOP System • Documented • Approved • Controlled • Reviewed periodically: take time to look at the process… • Effective date • Historic versions retained • Amendments documented KEMRI-Wellcome Trust Research Programme Ken Awuondo

8. SOP System • SOP To cover areas such as: • Format, control and review of SOPs • Sample handling- receipt, chain of custody, storage, repeat analysis, etc • Methods or control of methods • Equipment use and maintenance • Record keeping • QC procedures • Audit procedures KEMRI-Wellcome Trust Research Programme Ken Awuondo

9. SOP tracking • Numbering System: Example LCHEM 01 • Distribution: Electronic/paper • Retiring SOPs KEMRI-Wellcome Trust Research Programme Ken Awuondo

10. Who should write SOPs • Someone who understands the procedure • Use specified format KEMRI-Wellcome Trust Research Programme Ken Awuondo

11. Changing of SOPs • Within defined periodic reviews • An SOP can be changed at any time • You should not implement a new practice until the SOP has been updated • New version issue KEMRI-Wellcome Trust Research Programme Ken Awuondo

12. SOP training • Core of the staff training programme • Significant changes should result in training • SOP training- training should be focused on the process KEMRI-Wellcome Trust Research Programme Ken Awuondo

13. Common Problems with SOPs • Missing SOPs • SOPs are not followed • SOPs do not reflect current practice • Current revision of an SOP is not the one being used • Unofficial copies of SOPs are used • Contradictory SOPs KEMRI-Wellcome Trust Research Programme Ken Awuondo

14. THANK YOU ANY QUESTION? KEMRI-Wellcome Trust Research Programme Ken Awuondo