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STANDARD OPERATING
PROCEDURES
KEMRI-Wellcome Trust Research Programme
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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
3
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
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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
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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
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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
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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
8
SOP tracking
• Numbering System:
Example LCHEM 01
• Distribution:
Electronic/paper
• Retiring SOPs
KEMRI-Wellcome Trust Research Programme
Ken Awuondo
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Who should write SOPs
• Someone who understands the procedure
• Use specified format
KEMRI-Wellcome Trust Research Programme
Ken Awuondo
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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
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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
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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
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THANK YOU
ANY QUESTION?
KEMRI-Wellcome Trust Research Programme
Ken Awuondo
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