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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

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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

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KEMRI-Wellcome Trust Research Programme

• Someone who understands the procedure• Use specified format

Changing of SOPs

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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

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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