This is a ready-to-use pre-approval form for a planned deviation, sometimes called a temporary change or temporary exception: an intentional, pre-approved departure from an approved procedure or specification for a defined scope and duration. It is not for unplanned events found after the fact; those are covered by the deviation record and investigation report. Replace every <<FILL: ...>> placeholder with your own specifics. A worked filled specimen follows the template. Verify each cited regulation against the current source before you rely on it.
Document control header
| Field | Entry |
|---|---|
| Document title | Planned Deviation / Temporary Change Pre-Approval Request |
| Document number | <<FILL: FORM-ID, e.g. FORM-QA-021>> |
| Version | <<FILL: version, e.g. 1.0>> |
| Effective date | <<FILL: effective date>> |
| Document owner | <<FILL: role, e.g. Head of Quality Assurance>> |
| Applies to | <<FILL: sites / departments in scope>> |
When to use this form
Use this form when a specific, known circumstance requires a defined, temporary departure from an approved procedure, specification, or established standard, and the departure can be assessed and authorized before the affected activity happens. Do not use it as a substitute for fixing a procedure that no longer reflects how the work is actually done; a planned deviation requested repeatedly against the same step is a signal to open change control instead.
1. Request
| Field | Entry |
|---|---|
| Request number | <<FILL: PD-ID, e.g. PD-2026-0031>> |
| Requestor (name, role, date) | <<FILL>> |
| Procedure / specification affected | <<FILL: document number and clause>> |
| Approved requirement (as written) | <<FILL: the exact step, limit, or condition being modified>> |
| Requested modification | <<FILL: the exact modified step, limit, or condition>> |
| Rationale | <<FILL: why the approved requirement cannot be met as written for this instance, and why the modification is appropriate>> |
| Scope | <<FILL: specific batch(es), lot(s), run(s), or a defined, bounded set>> |
| Duration / expiry | <<FILL: specific date, batch count, or event that ends the authorization>> |
2. Prospective risk assessment
Complete this before execution, with the same rigor as a change control impact assessment. A planned deviation approved with no analysis of what could go wrong under the modified condition is not a risk-based decision, it is a rubber stamp.
| Question | Answer |
|---|---|
| What could the modification affect (product quality, patient safety, data integrity, a critical process parameter)? | <<FILL>> |
| What is the worst credible outcome under the modified condition? | <<FILL>> |
| What evidence supports that the modification will not produce that outcome (prior data, qualification, engineering rationale, literature)? | <<FILL>> |
| What additional testing, sampling, or verification will be performed specifically because of this modification? | <<FILL>> |
| What is the fallback if the additional verification fails? | <<FILL>> |
3. Approval (before execution)
| Role | Name | Signature | Date |
|---|---|---|---|
| Requestor | <<FILL>> | ||
| Area / process owner | <<FILL>> | ||
| Subject matter expert (if applicable) | <<FILL>> | ||
| Quality Assurance | <<FILL>> |
The QA approval date must precede the start of the affected activity. A planned deviation approved after the activity has already begun is, by definition, not a planned deviation; it is an unplanned one and must be handled as such.
4. Execution record
| Field | Entry |
|---|---|
| Batch(es) / lot(s) / run(s) actually covered | <<FILL>> |
| Confirmation the modification stayed within the approved scope | <<FILL: yes / no, detail if no>> |
| Additional verification results (from section 2) | <<FILL>> |
| Any unexpected observation during execution | <<FILL: none, or describe and cross-reference a new deviation if the event exceeded the approved scope>> |
5. Closure
| Field | Entry |
|---|---|
| Verification results meet the acceptance defined in section 2 | <<FILL: yes / no>> |
| Batch disposition impact (if any) | <<FILL: reference to disposition record, or "none, within approved scope">> |
| Recurrence count for this same modification in the trailing 12 months | <<FILL: number>> |
| If recurrence is 2 or more, change control opened to fix the underlying procedure | <<FILL: reference or rationale for not opening one>> |
| QA closure (name, signature, date) | <<FILL>> |
Acceptance criteria
- The request, rationale, scope, and duration are specific, not open-ended.
- The risk assessment in section 2 was completed and approved before the activity began, not reconstructed afterward.
- Additional verification specific to the modification was performed and its results are recorded.
- Execution stayed within the approved scope; anything outside it was captured as a separate, unplanned deviation.
- A recurring planned deviation against the same step triggered a change control evaluation rather than a further round of pre-approvals.
References
21 CFR 211.100 (written procedures); 21 CFR 211.192 (investigation of discrepancies, for the boundary with unplanned deviations). EU GMP Annex 1 (2022), section 1 (contamination control strategy references planned interventions as a controlled, documented, risk-assessed activity). EudraLex Volume 4, Part I, Chapter 1 (Pharmaceutical Quality System), deviation handling. ICH Q9, Quality Risk Management. ICH Q10, Pharmaceutical Quality System.
Confirm the current version and clause numbers of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
Illustrative planned deviation. Replace with your own.
| Field | Entry |
|---|---|
| Request number | PD-2026-0031 |
| Requestor | J. Alvarez, Manufacturing Supervisor, 03 Aug 2026 |
| Procedure / specification affected | BR-4410, section 6.2, coating pan inlet air temperature |
| Approved requirement | Inlet air temperature 55 to 65 degrees Celsius |
| Requested modification | Inlet air temperature 50 to 65 degrees Celsius, backup coating pan CP-02 only |
| Rationale | Primary coating pan CP-01 is down for scheduled preventive maintenance through 10 Aug 2026; qualified backup pan CP-02 has a different heat-exchanger response and engineering data shows 50 to 65 degrees Celsius achieves the same coating weight gain profile on CP-02 |
| Scope | Batches 26H0142 and 26H0143 only |
| Duration / expiry | Expires 10 Aug 2026 or on return of CP-01, whichever is first |
Prospective risk assessment:
| Question | Answer |
|---|---|
| What could the modification affect? | Coating weight gain and film uniformity, a critical quality attribute for this modified-release product |
| Worst credible outcome | Under-coating leading to a failed dissolution result |
| Supporting evidence | CP-02 qualification data (IQ/OQ/PQ, June 2024) and engineering heat-transfer comparison memo (Ref ENG-2026-018) both support equivalent coating performance at the modified range |
| Additional verification | In-process coating weight checked at 3 time points instead of the routine 1; dissolution testing added to both batches’ release panel in addition to the standard skip-lot schedule |
| Fallback if verification fails | Batch held; investigate as an unplanned deviation; disposition per the batch disposition SOP |
Approval: J. Alvarez (requestor), M. Chen (Manufacturing area owner), R. Gomez (QA), all signed 03 Aug 2026, prior to the start of batch 26H0142.
Execution record: both batches covered as scoped; coating weight checks at all 3 time points within the qualified range; no observation outside scope.
Closure: dissolution results for both batches met specification; QA closed 12 Aug 2026; this was the first use of this specific modification in the trailing 12 months, so no change control was triggered, but the register in section 5 will catch a second request against the same step.
This is the record that separates a planned deviation from a deviation with a prospective label stapled on: the risk was assessed and approved before the batch ran, the added verification was specific to the actual risk identified, and the recurrence check is what will catch it if this becomes a pattern instead of a one-off.
Common inspection findings this form prevents
- A “planned” deviation approved after the batch was already made, which is an unplanned deviation with the wrong label.
- A planned deviation approved with no documented risk assessment, just a stated intention to modify the procedure.
- Scope or duration left open-ended, so the modification quietly becomes the new normal without ever going through change control.
- The same planned deviation requested repeatedly with no escalation to fix the underlying procedure.
- No additional verification tied specifically to the risk the modification introduces, relying only on the routine testing that was already planned regardless.
How to adapt this form
- Set your document number, owner, and effective date in the header.
- Point the change control cross-reference to your real change control SOP and set your own recurrence threshold for when a repeated planned deviation must trigger it.
- Adjust section 2 to match your risk assessment methodology if you use a formal scoring tool rather than a narrative format.
- Confirm every regulation in the references against the current published version before issue.