This is a ready-to-use content plan for an eCTD sequence, the controlling document regulatory operations builds before publishing starts. It maps every planned leaf to its CTD heading, its source document, and its lifecycle operation, so that “what replaces what” is decided and reviewed before anyone opens a publishing tool. Replace every <<FILL: ...>> placeholder. This content is educational reference, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Plan ID | <<FILL: PLAN-ID>> |
| Application / product | <<FILL: application number, product>> |
| Sequence number | <<FILL: e.g. 0004>> |
| Submission type | <<FILL: original / amendment / supplement / variation / response, etc.>> |
| Region | <<FILL>> |
| Prepared by | <<FILL>> |
| Date | <<FILL>> |
Content and lifecycle map
| # | CTD heading | Content / leaf title | Source document (version) | Lifecycle operation | Prior leaf referenced (if replace/append/delete) | Owner |
|---|---|---|---|---|---|---|
| 1 | <<FILL: e.g. 3.2.P.5.1>> | <<FILL>> | <<FILL>> | <<FILL: new/replace/append/delete>> | <<FILL: sequence + leaf, or N/A>> | <<FILL>> |
| 2 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 3 | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Add a row for every planned leaf. Do not begin publishing until every row has a confirmed lifecycle operation and, for replace/append/delete, the specific prior leaf it acts on.
Reconciliation checkpoints
| # | Checkpoint | Confirmed | Owner |
|---|---|---|---|
| 1 | Every number, conclusion, and specification stated in a Module 2 summary matches the corresponding Module 3, 4, or 5 source | <<FILL>> | <<FILL>> |
| 2 | Every replace operation references the correct prior leaf, verified against the current view, not assumed from memory | <<FILL>> | <<FILL>> |
| 3 | Source documents feeding this sequence are approved, current, and signed under the quality system, not draft copies | <<FILL>> | <<FILL>> |
| 4 | Regional Module 1 forms and metadata (application number, submission type) are correct and consistent across every file | <<FILL>> | <<FILL>> |
Acceptance criteria
- Every leaf planned for the sequence appears in the map with a confirmed CTD heading and lifecycle operation before publishing begins.
- Every
replaceorappendoperation names the specific prior leaf it acts on; “replace the old spec” is not sufficient, the leaf ID or heading and sequence number is. - All four reconciliation checkpoints are confirmed before the sequence is submitted for validation.
- Source documents are approved versions, traceable to the quality system’s document control record.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Regulatory affairs / submission lead | <<FILL>> | ||
| Quality assurance | <<FILL>> |
References
ICH M4 (R4), Organisation of the Common Technical Document. ICH M8, Electronic Common Technical Document (eCTD) Implementation Guide. FDA and/or EU regional Module 1 specification, current version.
Confirm the current version of each reference before issue.
Filled specimen
A partial completed content plan for an example supplement sequence. Illustrative only.
| # | CTD heading | Content / leaf title | Source document (version) | Lifecycle operation | Prior leaf referenced | Owner |
|---|---|---|---|---|---|---|
| 1 | 3.2.P.5.1 | Specification, drug product, v3 | SPEC-DP-014 v3.0, approved | replace | Sequence 0000, 3.2.P.5.1 | J. Alvarez |
| 2 | 2.3.P.5 | QOS update reflecting tightened impurity limit | QOS-2026-07, approved | replace | Sequence 0000, 2.3.P.5 | J. Alvarez |
| 3 | 1.12.3 | Cover letter for this supplement | CL-2026-0817, approved | new | N/A | R. Chen |
Checkpoint 1 (Module 2 vs Module 3 consistency) is the reason rows 1 and 2 are both in this sequence together: the specification change in row 1 is not filed alone, because doing so would leave the Module 2 QOS quoting the old limit against a Module 3 specification that has already changed. That pairing, catching a dependent Module 2 update before it becomes a mismatch a reviewer finds instead, is exactly what this plan is for.
Common findings this plan prevents
- A specification or report is replaced in Module 3 but the corresponding Module 2 summary is filed unchanged, creating an internal inconsistency the reviewer finds.
- A
replaceoperation is built against the wrong prior leaf because no one confirmed the current view before publishing. - Publishing starts before source documents are approved, so the rendered PDF does not match what QA later approves.
How to adapt this plan
- Set your application, sequence number, and submission type in the header.
- List every planned leaf with its real CTD heading and confirm the lifecycle operation against the actual current view of the application.
- Add product- or region-specific reconciliation checkpoints your organization has learned it needs.
- Confirm every regulation in the references against the current published version before issue.