Outline of an Standard Operating Procedures- ICH

The general outline of an SOP is as follows:

• Number and title of procedure
• Purpose (brief summary in a few lines)
• Other procedures simultaneously involved
• Personnel involved and procedure: Who is responsible for carrying out the procedure?
• When and How should the procedure be carried out?
• Date of version in use plus ‘replaces previous version of . . .’
• Name of author and person in charge who approved this version
• Each SOP has a number. Not every SOP has an accompanying checklist. Please note that the checklists are numbered according to the corresponding SOP number.

Revision and updating of Standard Operating Procedures : SOPs must be reviewed and updated on a regular basis. When they are first introduced to the department, they may need revision after a few months. However, once they have been adjusted to your needs they will probably only need revising every two years or so, but we recommend an annual review. Revision is best done as a team task. The procedures should be examined and rewritten where appropriate, then approved and signed. The old version should be archived. It should not be disposed of because it can be of use  some time after a study is completed that Regulatory Agency questions might arise, and you may be required to show the procedures you used to follow.