This is a ready-to-use record. Replace every <<FILL: ...>> placeholder with your own specifics and maintain it under your document control system. A worked filled specimen follows the template. It is an educational aid to adapt and verify, not a compliance guarantee.
Record control
| Field | Entry |
|---|---|
| Record title | Controlled Document Retirement and Destruction |
| Record number | <<FILL: record ID>> |
| Document control SOP reference | <<FILL: SOP-ID>> |
| Owner | <<FILL: document control administrator>> |
Purpose
Make retirement and destruction of a controlled document deliberate, recorded actions rather than things that happen by neglect. Retirement removes a document from active use; destruction, later, disposes of the archived copy only after the retention period has elapsed. Destroying a record too early leaves nothing to defend a batch; keeping an obsolete version in use lets it resurface. Both are avoided by making each step an approved, documented event.
1. Retirement
| Field | Entry |
|---|---|
| Document number, title, version | <<FILL>> |
| Reason for retirement | <<FILL: process discontinued / system decommissioned / superseded>> |
| Superseded by (if any) | <<FILL: new document or N/A>> |
| Controlled copies retrieved and reconciled | Yes / N/A |
| Removed from master list and point of use | Yes |
| Moved to archive | Yes, location <<FILL>> |
| Retention period and end date | <<FILL: period, end date>> |
| Retired by (name, date) | <<FILL>> |
| QA approval (name, date) | <<FILL>> |
2. Destruction (only after retention has elapsed)
| Field | Entry |
|---|---|
| Retention period confirmed elapsed | Yes, end date <<FILL>> |
| No legal, investigation, or inspection hold in place | Confirmed |
| Items destroyed (document and associated records) | <<FILL: describe>> |
| Destruction method | <<FILL: secure shredding / controlled electronic deletion>> |
| Authorized by (name, date) | <<FILL>> |
| Destruction performed by (name, date) | <<FILL>> |
| QA approval (name, date) | <<FILL>> |
Acceptance criteria
- Retirement removed the document from the master list and every point of use, with controlled copies reconciled.
- The retention period is defined, and destruction happens only after it has elapsed and no hold is in place.
- Destruction states what was destroyed, when, by whose authority, and confirms the retention period was met.
- The archived document remained retrievable for the full retention period before destruction.
References
21 CFR 211.180 (record retention: batch records at least one year past batch expiry, longer for certain records; readily available for inspection). EU GMP EudraLex Volume 4, Chapter 4, Documentation (retention of batch documentation, at least one year past expiry or five years past QP certification, whichever is longer). ISO 13485:2016 clause 4.2.5 (control of records; retention for the lifetime of the device, not less than two years from release), incorporated by reference under FDA’s QMSR (effective 2 February 2026), for combination products and operations following that standard.
Confirm the current retention requirement for each record type and the current version of each reference before you rely on it.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Document control | <<FILL>> | ||
| Approver (QA) | <<FILL>> |
Filled specimen
A retirement and, years later, a destruction, worked:
| Field | Entry |
|---|---|
| Document number, title, version | SOP-QC-041, Manual Titration Method, Rev D |
| Reason for retirement | Instrument decommissioned; method replaced by SOP-QC-072 |
| Superseded by | SOP-QC-072 |
| Controlled copies retrieved and reconciled | Yes, 2 copies retrieved and destroyed on retirement |
| Removed from master list and point of use | Yes, 15 Feb 2024 |
| Moved to archive | Yes, records archive shelf 12 |
| Retention period and end date | Batch-linked; latest dependent batch expiry plus one year, end date 30 Jun 2026 |
| Retired by | D. Cho, 15 Feb 2024 |
Destruction section, completed after the retention end date:
| Field | Entry |
|---|---|
| Retention period confirmed elapsed | Yes, end date 30 Jun 2026 |
| No hold in place | Confirmed, no open investigation or inspection referencing the method |
| Items destroyed | SOP-QC-041 archived master and its distribution and training records |
| Destruction method | Secure shredding, witnessed |
| Authorized by | R. Mehta, 15 Jul 2026 |
| Destruction performed by | D. Cho, 15 Jul 2026 |
Retirement in 2024 removed the method from use and reconciled its copies; destruction waited until the batch-linked retention period had elapsed and no hold existed, and it names what was destroyed and under whose authority. That is what separates legitimate disposal from a data integrity problem.
Common inspection findings this record prevents
- A retired document quietly left on the master list or at a workstation.
- A record destroyed before its retention period elapsed, or with an open hold in place.
- Destruction with no record of what was destroyed, when, or under whose authority.
- Retention periods decided ad hoc rather than defined by record type.
How to adapt this record
- Set the retention driver for each record type in your retention schedule and reference it here.
- Add a hold check that covers legal, investigation, and inspection holds before any destruction.
- Tie retirement to the master-list update and controlled-copy reconciliation so all three happen together.
- Confirm each retention requirement and reference against its current published version before issue.