Standard Operating Procedure for eCTD Publishing Workflow Management
| Department | Regulatory Affairs |
| SOP No. | RA/2026/684 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 12/04/2026 |
| Effective Date | 12/04/2026 |
| Review Date | 12/04/2028 |
Purpose
This Standard Operating Procedure (SOP) defines the systematic approach for managing the eCTD (electronic Common Technical Document) publishing workflow to ensure timely, accurate, and compliant preparation, quality control, and dispatch of regulatory submissions. It supports regulatory compliance objectives by establishing controls to maintain data integrity, traceability, and documentation quality throughout the eCTD publishing lifecycle.
Scope
This SOP applies to all activities involved in the compilation, publishing, quality control, and dispatch of eCTD submissions within the Regulatory Affairs department. It covers electronic document management systems, publishing software, quality checks, and dispatch mechanisms related to regulatory dossiers for pharmaceutical products. This SOP excludes non-eCTD regulatory document types and is not applicable to submission content creation or regulatory strategy development.
Responsibilities
The following functional roles are responsible under this SOP:
- Regulatory Affairs Associate: Execution of document compilation, formatting, and eCTD publishing tasks.
- Quality Control Analyst: Performing detailed QC checks on the eCTD packages for compliance and completeness.
- Regulatory Affairs Supervisor: Reviewing the publishing outputs and QC results for accuracy and compliance.
- Document Control Coordinator: Maintaining version control and archival of publishing records.
- Dispatch Coordinator: Ensuring proper dispatch of the finalized eCTD submissions to regulatory authorities.
Accountability
The Regulatory Affairs Department Head is accountable for implementing this SOP, ensuring compliance, conducting periodic reviews, addressing nonconformities, escalating issues appropriately, and verifying the SOP’s ongoing effectiveness within the department.
Procedure
1. Preparation and Prerequisites: Verify availability and currency of all regulatory documents and modules required for the submission according to applicable guidelines. Confirm access to eCTD publishing software and related tools is functional and authorized. Ensure compliance with current regulatory specifications and internal change controls.
2. Document Compilation and Formatting: Collect all dossier components including Module 1 administrative data and Modules 2-5 scientific content. Validate document formats, naming conventions, and metadata as per eCTD standards. Arrange files logically within the electronic folder structure ensuring optimal navigation and internal consistency.
3. eCTD Publishing Execution: Use validated publishing software to compile the eCTD sequence, including appropriate backbone structures and XML backbone files. Incorporate hyperlinked tables, consistent bookmarks, and correct sequencing. Generate eCTD validation reports and review for system errors or warnings.
4. In-Process Controls and Quality Checks: Conduct initial self-review of the published output focusing on navigation, links, file integrity, and compliance with regulatory specifications. Submit to Quality Control Analyst for independent QC following a defined checklist to verify completeness, format accuracy, and regulatory adherence.
5. Review and Approval: Address any deficiencies or deviations identified during QC. Regulatory Affairs Supervisor reviews final eCTD package and QC reports for approval. Obtain documented sign-off prior to dispatch.
6. Documentation and Record Keeping: Archive all working documents, software logs, QC checklists, review notes, approval signatures, and final eCTD submission packages in secured document management systems. Maintain records with traceability and retrievability according to document retention policies.
7. Submission Dispatch: Prepare and send the eCTD submission to the designated regulatory authority via approved electronic transmission methods. Confirm receipt and maintain acknowledgement records.
8. Handling Deviations: Document any deviations or nonconformance encountered during the publishing process in the deviation log. Initiate corrective and preventive actions as per the deviation management SOP.
9. Periodic Review and Training: Conduct regular training of personnel involved in the workflow. Periodically review SOP effectiveness and make required updates to adapt to regulatory changes or process improvements.
Abbreviations
eCTD – electronic Common Technical Document
QA – Quality Assurance
QC – Quality Control
SOP – Standard Operating Procedure
XML – Extensible Markup Language
GMP – Good Manufacturing Practice
Documents
The following documents are required to support the eCTD publishing workflow:
- eCTD Publishing Checklist (Annexure-1)
- eCTD Quality Control Report (Annexure-2)
- eCTD Submission Dispatch Log (Annexure-3)
References
International Council for Harmonisation (ICH) M4 Common Technical Document guidelines, FDA eCTD guidance documents, EMA Module 1 requirements, internal Quality Management System relating to documentation and electronic submissions, ISO 9001:2015 quality standards, and corporate IT validation policies applicable to eCTD publishing software.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: eCTD Publishing Checklist
Purpose: To systematically verify all relevant tasks, document formats, file naming, and folder structures before finalizing the eCTD publishing.
| Checklist Item | Status | Comments |
|---|---|---|
| All Module documents received | Yes | Complete per submission scope |
| File naming conventions conformed to standard | Yes | Checked for consistency |
| Folder structures validated as per eCTD specs | Yes | Structure matches submission sequence |
| Hyperlinks and bookmarks verified | Yes | All links operational |
| Metadata and XML backbone files generated correctly | Yes | Validated with publishing software |
| Pre-submission validation run with no major errors | Yes | Minor warnings reviewed and justified |
| Checklist reviewed and signed | Yes | Completed on 10/04/2026 |
Annexure-2: eCTD Quality Control Report
Purpose: To document the independent QC assessment verifying compliance of the eCTD package with regulatory and internal requirements before approval and dispatch.
| QC Parameter | Result | Comments |
|---|---|---|
| Completeness of dossier | Pass | All modules present |
| File formats and sizes | Pass | Conforms to regulatory limits |
| Navigation and link integrity | Pass | No broken links identified |
| Consistency of metadata and XML files | Pass | Validated using XML validator |
| Absence of errors/warnings post-publishing | Pass | Minor warnings addressed |
| QC by | QC Analyst | Checked on 11/04/2026 |
| Reviewed by | Regulatory Affairs Supervisor | Approved on 12/04/2026 |
Annexure-3: eCTD Submission Dispatch Log
Purpose: To record the dispatch details and acknowledgements for eCTD submissions sent to regulatory authorities.
| Dispatch Date | Submission ID | Recipient Authority | Transmission Method | Receipt Confirmation | Comments |
|---|---|---|---|---|---|
| 12/04/2026 | eCTD-RA-2026-001 | FDA | Secure FTP | Received 12/04/2026 14:30 | Confirmed successful transmission |
| 12/04/2026 | eCTD-EMA-2026-002 | EMA | Web Portal Upload | Received 12/04/2026 16:00 | Receipt acknowledged electronically |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 12/04/2026 | 1.0 | Initial issue | New SOP creation |