Author:
__________________________________________________
Name
__________________________________________________ ____________________
Signature Date
Authorised by:
__________________________________________________
Name
__________________________________________________
Title
__________________________________________________ ____________________
Signature Date
PURPOSE
SCOPE
DEFINITIONS/ABBREVIATIONS
[Define all relevant terms and abbreviations that will be used in the SOP.]
[Include details of any related SOPs referred to in the SOP as well as other documents,
Regulations or Guidelines, e.g. ICH GCP Guidelines, National requirements etc.]
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STANDARD OPERATING PROCEDURE: Dr XXXXX Site
Title: Production, Review, Approval & Archiving of Standard Operating
Procedures (SOPs)
PROCEDURES
[The procedure is to be written stepwise, using a clear format (eg: tables) indicating step
number and action. When referring to other SOPs, include the non-version specific SOP
number.]
Step Action
Appendix Listing
REVISION HISTORY
[Include brief statement specifying the reason(s) for revision and listing the superseded
versions.]
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