This is a ready-to-use controlled log. It is the single index that tells you what procedures exist, which version is current, and which are due for review. Replace each <<FILL: ...>> placeholder with your own specifics, keep it under document control, and drive periodic review from the next-review-due column. A filled specimen follows. Verify each cited regulation against the current source before you rely on it.
Document control header
| Field | Entry |
|---|---|
| Log title | SOP Master List and Periodic Review Schedule |
| Log number | <<FILL: LOG-ID, e.g. LOG-QA-002>> |
| Version | <<FILL: version>> |
| Owner | <<FILL: role, e.g. Document Control Lead>> |
| Applies to | <<FILL: sites / quality system in scope>> |
| Retention | Life of the quality system; superseded entries retained per the records retention schedule, not less than <<FILL: retention period>> |
Purpose
To hold one controlled record of every effective SOP so that: current versions are unambiguous, ownership is assigned, periodic review is scheduled and tracked, and no procedure quietly falls out of date. An inspector who asks “how do you know your procedures are current” should be handed this log.
Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| SOP number | Controlled ID | Yes | Document control | At issue |
| Title | Text | Yes | Document control | At issue |
| Owning function / role | Role, not a person | Yes | Document control | At issue |
| Current version | Version ID | Yes | Document control | At each revision |
| Effective date | Date | Yes | Document control | At each revision |
| Review cycle | Months (risk based) | Yes | Owner + QA | At issue and at each review |
| Last review date | Date | Yes | Owner | At each periodic review |
| Next review due | Date (= last review + cycle) | Yes | Document control | At each review |
| Risk class | High / Medium / Low | Yes | Owner + QA | At issue |
| Status | Effective / Under revision / Retired | Yes | Document control | On any state change |
| Training current | Yes / No / N/A | Yes | Training coordinator | At issue and revision |
| Linked change control | CC number or N/A | Yes when revised | Document control | At each revision |
Instructions for use
- Add a row when a new SOP becomes effective; never let an effective SOP exist off this list.
- Set the review cycle from risk: a shorter cycle for procedures governing critical control points or fast-changing processes, a longer cycle for stable low-risk procedures. Record the basis for the cycle in the risk class column.
- Compute next review due as the last review date plus the cycle. Run a report on this column monthly and start each review before its due date, not after.
- On any revision, update current version, effective date, last review date, next review due, training current, and the linked change control in the same entry; move the prior version to the archived record.
- On retirement, set status to Retired, record the rationale in the retirement record, and confirm no effective document still references it.
- A blank required field is itself a finding; use N/A explicitly rather than leaving a cell empty.
Acceptance criteria
- Every effective SOP appears exactly once with a current version and effective date.
- No entry is past its next-review-due date without a documented reason and a recovery plan.
- Review cycle is set from a stated risk basis, not a single default for everything.
- Retired procedures are marked Retired with no live inbound references, not deleted from the record.
- No procedure in Effective status has Training current set to No.
References
21 CFR 211.100(b) (procedures followed and documented at the time of performance), 211.180 (general records requirements). EudraLex Volume 4, GMP Chapter 4 (Documentation), on document management and periodic review. ICH Q10 (Pharmaceutical Quality System) for the lifecycle management of the document system.
Confirm the current version and clause numbers before issue.
Filled specimen
Illustrative rows; replace with your own inventory.
| SOP number | Title | Owner | Ver | Effective | Cycle | Last review | Next due | Risk | Status | Training current | Change control |
|---|---|---|---|---|---|---|---|---|---|---|---|
| SOP-QA-014 | Audit Trail Review for GxP Systems | QA | 2.0 | 12-Jan-2026 | 24 mo | 12-Jan-2026 | 12-Jan-2028 | High | Effective | Yes | CC-2025-118 |
| SOP-QC-032 | Incoming Raw Material Sample Receipt | QC | 1.0 | 05-Aug-2026 | 24 mo | 05-Aug-2026 | 05-Aug-2028 | High | Effective | Yes | New |
| SOP-MFG-007 | Line Clearance | Manufacturing | 3.1 | 20-Mar-2025 | 24 mo | 20-Mar-2025 | 20-Mar-2027 | High | Effective | Yes | CC-2025-041 |
| SOP-QA-001 | Writing and Maintaining SOPs | QA | 1.0 | 01-Jul-2026 | 36 mo | 01-Jul-2026 | 01-Jul-2029 | Medium | Effective | Yes | New |
| SOP-HR-003 | Meeting Minutes Format | Admin | 1.2 | 02-Feb-2023 | 36 mo | 02-Feb-2023 | 02-Feb-2026 | Low | Under revision | No | CC-2026-009 |
The bottom row is the one to notice: SOP-HR-003 passed its next-review-due date and is now Under revision with training not current, and it carries a linked change control showing the revision is in progress. A monthly report on the next-review-due column is what surfaces a row like this before an inspector does, which is the entire point of keeping the schedule in the same log as the inventory.
Common inspection findings this log prevents
- A procedure was in use years past its review cycle and no longer matched practice, with nothing tracking that it was overdue.
- Two versions of the same SOP were both in circulation because the current version was not recorded in one authoritative place.
- A retired procedure was still referenced by an effective document because the retirement was never propagated.
- Periodic review was claimed but no schedule or record existed to show when reviews were actually due or performed.
How to adapt this log
- Set your log number, owner, and retention in the header.
- Match the review-cycle values to your own risk-based document policy and record the basis for each.
- Automate the next-review-due report if your document management system supports it, so the monthly check is a query rather than a manual scan.
- If work instructions and controlled forms are tracked separately, cross-reference their master lists here so the whole controlled set is reachable from one place.
- Confirm every regulation in the references against the current published version before issue.