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www.GlobalHealthLaboratories.org. This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). - PowerPoint PPT Presentation
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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.
www.GlobalHealthLaboratories.org
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KEMRI-Wellcome Trust Research Programme
STANDARD OPERATING PROCEDURES
SOP Definition
3Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• 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
Functions of SOPs
4Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• 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
SOP Requirement
5Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• 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
SOP Requirement
6Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• Personnel:– Have access to appropriate SOPs– Responsible for complying with SOPs instructions– Communicate and document to responsible
person any deviation from SOP instruction
SOP System
7Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• Documented• Approved• Controlled• Reviewed periodically: take time to look at the
process…• Effective date• Historic versions retained• Amendments documented
SOP System
8Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• 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
SOP tracking
9Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• Numbering System:Example LCHEM 01
• Distribution:Electronic/paper
• Retiring SOPs
Who should write SOPs
10Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• Someone who understands the procedure• Use specified format
Changing of SOPs
11Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• 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
SOP training
• Core of the staff training programme• Significant changes should result in training• SOP training- training should be focused on
the process
Ken Awuondo 12
KEMRI-Wellcome Trust Research Programme
Common Problems with SOPs
13Ken Awuondo
KEMRI-Wellcome Trust Research Programme
• 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
THANK YOU
ANY QUESTION?
Ken Awuondo 14
KEMRI-Wellcome Trust Research Programme
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