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-yyy

Author:

__________________________________________________
Name

__________________________________________________ ____________________
Signature Date

Authorised by:

__________________________________________________
Name

__________________________________________________
Title

__________________________________________________ ____________________
Signature Date

PURPOSE

This SOP describes the process to ensure all institute SOPs for Clinical Trial Units are
prepared, reviewed, approved & archived in a consistent manner. This will also ensure
that SOPs will be updated in timely manner.

SCOPE

This SOP applies to all the Clinical Trial Unit members.

DEFINITIONS/ABBREVIATIONS

SOP : Standard Operating Procedures

Author : Any site staff who reviews or is responsible for the activities/ procedures
stated in the SOP.
Authorized Reviewer: Institution head / Quality Assurance Personnel
Authorized personnel: please complete
GEN-001.01 Page 1 of 4
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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-yyy

RELATED SOPs AND OTHER DOCUMENTS

ICH GCP
Indian GCP
Schedule Y of Drug & Cosmetic Act 1940

PROCEDURES

1. Writing the SOP

Step Action

1.1 Based on the requirement an author (s) should write down a respective SOP.

1.2 A standard format should be used by the author(s) when writing SOPs. A template for
the preparation is shown in Appendix 1.

1.3 The SOP be numbered as per the process described in section 3.

2. Distribution, Review & Approval of the draft SOP

Step Action

2.1 Draft SOP should be distributed to the reviewer(s).

2.2 Reviewed SOP should be returned back to the author(s) with comments &
suggestions.

2.3 Author(s) should appropriately incorporate the comments & suggestions into the draft
SOP.

2.4 Updated SOP should be distributed to the reviewers for final comments.

2.5 After final agreement, the SOP should be finalized & approved by authorized
personnel

3. Numbering of SOP

Step Action

3.1 Master list of SOPs including version number & date should be maintained.

GEN-001.01 Page 2 of 4
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-yyy

3.2 Each SOP is assigned a unique number as follows;

First three digits should indicate the department to which the SOP belongs. (e.g. GEN)
Second two digits should indicate the SOP number in sequential order & separated by
the ‘-‘ from first three digits. (e.g. -01)
Last two digits is version number separated by ‘.’ From the SOP number (e.g. .01)
Example of the complete SOP number : GEN-01.01

4. SOP Enactment & Training

Step Action

4.1 Once the SOP has been approved, effective date should be assigned to the SOP. This
date should be of one month after the approval, giving enough time to all staff to get
training on the SOP.

4.2 Training of the SOP should be documented in the training record.

5. SOP Distribution

Step Action

5.1 All the site staff should be informed of new SOP being made effective.

7. SOP Revision

Step Action

6.1 Every SOP should be revised as or when required or at least once in every two years.

6. SOP Archiving

Step Action

6.1 All retired and superseded SOPs should be archived in archive file.

6.2 Archive file should be maintained and made available in the event of audit.

GEN-001.01 Page 3 of 4
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-yyy

Appendix Listing

Appendix 1 : SOP Template

REVISION HISTORY

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

Revision # Document
New SOP N/A

GEN-001.01 Page 4 of 4
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