Standard Operating Procedure Page 2
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STANDARD OPERATING PROCEDURE
SOP No: ____________
SOP Title: ________
1.
PURPOSE
A brief description of the purpose of the SOP, it should describe why the SOP is
required (e.g. compliance with GCP and other internal procedures and guidelines).
Any regulations or procedures referred to in “Purpose” section should be identified.
The source should be given in the reference section rather than direct quotes.
2.
INTRODUCTION
A general introduction, with a statement of rationale.
3.
SCOPE
A statement that outlines the areas and context covered by the SOP.
If there are any areas in which this SOP specifically does NOT apply, these should
also be mentioned.
4.
DEFINITIONS
When appropriate, a list of definitions should be included for terms used in the SOP.
Acronyms and abbreviations should be explained at the point of use within the SOP
and not listed in this section.
5.
RESPONSIBILITIES
A summary of the roles listed in the procedure and the responsibilities of each role
holder for the procedures detailed in the SOP.
The details of the responsibilities should be a brief list of the key tasks performed.
This section should not be a complete summary of the SOP.
6.
SPECIFIC PROCEDURE
This section is the main text of the SOP. It details the procedure for the task to be
performed.
There should be sufficient detail, clearly expressed, to enable a trained person to
perform the procedure without supervision.
There should also be sufficient detail to enable a trained person to use the document
to train others to perform the task.
The use of flow diagrams may be useful, especially in complex procedures.
7.
FORMS/TEMPLATES TO BE USED
Where Forms/Templates are referenced in the text, the numbers and titles are listed
under this section.
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