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STANDARD OPERATING PROCEDURE: Dr XXXXX Site

Title: Production, Review, Approval & Archiving of Standard Operating


Procedures (SOPs)

SOP No.: GEN-01 Version No.: 01 Effective Date: dd-mmm-yyyy

Author:

__________________________________________________
Name

__________________________________________________ ____________________
Signature Date

Authorised by:

__________________________________________________
Name

__________________________________________________
Title

__________________________________________________ ____________________
Signature Date

PURPOSE

[Include a brief description of the purpose of the SOP.]

SCOPE

[Describe to whom and under which circumstances the SOP applies.]

DEFINITIONS/ABBREVIATIONS

[Define all relevant terms and abbreviations that will be used in the SOP.]

RELATED SOPs AND OTHER DOCUMENTS

[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.]

XXX-XX.XX Page 1 of 2
Confidential
STANDARD OPERATING PROCEDURE: Dr XXXXX Site
Title: Production, Review, Approval & Archiving of Standard Operating
Procedures (SOPs)

SOP No.: GEN-01 Version No.: 01 Effective Date: dd-mmm-yyyy

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

[Include all relevant appendixes/ forms]

REVISION HISTORY

[Include brief statement specifying the reason(s) for revision and listing the superseded
versions.]

SOP Page (s) Description of change(s) Superseded


Revision # Document
New SOP N/A

XXX-XX.XX Page 2 of 2
Confidential

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