GMP SOP Periodic Review Tracker Worksheet
Overdue SOPs are a common audit finding because nobody owns the calendar. This tracker gives document control a single list showing the interval, how long since each review and which SOPs are late.
| SOP number | Title | Owner | Department | Review interval (days) | Days since last review | Days remaining | Overdue (1 = yes) | Next review due | |
|---|---|---|---|---|---|---|---|---|---|
320 | 0 | ||||||||
-50 | 1 | ||||||||
245 | 0 | ||||||||
430 | 0 | ||||||||
-35 | 1 |
Review intervals are set by your quality system, often one to three years depending on risk. Update days since last review each time you open the file, or replace it with the review date and calculate in Excel.
Automatic SOP review reminders
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How to use the tracker
List every effective SOP with its owner and department. Enter the review interval from your document control SOP and the days since the last review or approval. The sheet shows days remaining and flags overdue lines, plus the percentage overdue in the summary. Export to Excel and send the overdue list to each owner at the start of the month. Add the date of the next review as a plain text reference.
- Use one row per controlled SOP version, not per file
- Add a column in Excel for the change control number if the review leads to revision
What the rules say
GMP regulations do not fix one interval. EU GMP Chapter 4 expects documents to be regularly reviewed and kept up to date, and 21 CFR 211.100 requires written procedures to be reviewed and approved by the quality control unit. Your interval is a risk based choice that you document. Critical procedures, such as aseptic processing or deviation handling, are often reviewed more often than general housekeeping SOPs.
Common mistakes
Teams often extend the review date by email without a record, or treat a review as done when the owner simply signs without reading. A periodic review should confirm the SOP matches current practice, regulations and any linked changes since the last review. If no change is needed, record that conclusion and keep evidence. Do not let reviews bunch up; spread the due dates over the year.
- Do not allow silent extensions
- Review the SOP against deviations raised since the last review
- Check the referenced forms and annexes still exist
Frequently Asked Questions
How often should SOPs be reviewed?
There is no universal figure. Two years is common for routine procedures and one year for critical or high risk ones. Define it in your document control SOP and be able to justify the choice during an inspection.
Is an overdue SOP a deviation?
Many sites treat it as a quality system event or a deviation, especially when it is critical. At minimum it needs an owner, a new due date and a reason. Follow your own procedure for classification.
Can I use the same tracker for forms and work instructions?
Yes, as long as each controlled document is listed. Add a type column in your Excel copy if you want to filter forms, work instructions and SOPs separately.
What counts as a periodic review?
A documented confirmation that the content is still accurate, complies with current regulations and matches actual practice. Where changes are needed, it should trigger a change control and a new revision.
If your document control lives in SharePoint, an ERP module or a DMS and you want automatic reminders and overdue dashboards, Netray can build it around your existing system.
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