Standard Operating Procedure for eCTD Sequence Preparation and Technical QC
| Department | Regulatory Affairs |
| SOP No. | RA/2026/685 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 12/04/2026 |
| Effective Date | 12/04/2026 |
| Review Date | 12/04/2028 |
Purpose
This SOP defines the standardized process for preparation and technical quality control (QC) of electronic Common Technical Document (eCTD) submission sequences. It ensures accurate, compliant, and timely compilation, validation, and verification of eCTD sequences before regulatory submission. The procedure supports regulatory compliance with submission requirements, enhances data integrity, and minimizes risks of review delays due to technical non-conformities.
Scope
This SOP applies to all activities related to the preparation, technical QC, validation, and dispatch of eCTD sequences within the Regulatory Affairs department. It covers electronic document assembly, sequence validation using authorized software, troubleshooting, and final submission readiness check. The scope includes all product dossiers requiring eCTD submission in regulated markets. Excluded are non-eCTD paper submissions, regulatory strategy development, and post-submission regulatory interactions.
Responsibilities
The Regulatory Affairs Associate is responsible for preparation and assembly of eCTD sequences. The Regulatory Affairs QC Specialist conducts technical quality control, validation, and verification of sequence compliance. The Regulatory Affairs Supervisor oversees the process execution, addresses discrepancies, and escalates issues. The Regulatory Manager reviews and approves final submission packages. The Document Controller manages versioning, archiving, and record retention.
Accountability
The Head of Regulatory Affairs is accountable for ensuring effective implementation, compliance to this SOP, periodic review, training of personnel, handling escalations, and confirming the SOP’s ongoing suitability and effectiveness.
Procedure
1. Preparation
Identify the regulatory requirements applicable to the submission sequence. Gather finalized dossier modules, documents, and updated client or project data. Ensure all supporting documents meet current specifications and templates as per regulatory guidelines.
2. Prerequisites
Verify availability of validated eCTD publishing software and supported technical infrastructure. Confirm access rights for designated personnel to the regulatory submission system. Confirm that all incoming documents have undergone prior quality review and approval.
3. Sequence Assembly
Import and organize dossier modules and documents into the eCTD publishing software following the required folder structure and naming conventions. Generate preliminary table of contents and validate linkages and bookmarks to ensure navigability. Cross-check metadata accuracy including headers, sequence numbers, and document identifiers.
4. Technical Quality Control and Validation
Perform automated validation checks using authorized eCTD validation tools to detect technical compliance issues such as incorrect file formats, naming errors, broken hyperlinks, or incomplete sections. Manually review the sequence for formatting consistency and completeness. Document all deviations or non-conformities in the QC checklist.
5. Handling Deviations
Raise deviation reports for any technical errors or missing documents detected during validation. Coordinate with relevant teams to resolve discrepancies before finalization. Re-validate the corrected sequence as necessary.
6. Approvals
Obtain requisite approvals from the Regulatory Affairs Supervisor and Manager after successful technical QC. Record approval dates and versions in the submission log.
7. Documentation and Record Retention
File all QC checklists, validation reports, deviation documents, and approval records in the regulatory documentation system per current Good Manufacturing Practices (cGMP) and company policies. Ensure sequence files and metadata are archived securely and accessible for audits.
8. Dispatch and Submission
Prepare final eCTD sequence package for electronic submission according to the regulatory authority’s transmission specifications. Coordinate with submission teams for dispatch and confirm receipt acknowledgement. Log submission details in the tracking system.
9. Review and Continuous Improvement
Participate in periodic reviews of this SOP and related procedures to incorporate regulatory updates and lessons learned. Provide feedback for process optimization and tool enhancements.
This procedure ensures a controlled, compliant, and auditable process that mitigates submission errors, enhances regulatory responsiveness, and maintains data integrity during eCTD sequence preparation and technical QC activities.
Abbreviations
eCTD – Electronic Common Technical Document
QC – Quality Control
SOP – Standard Operating Procedure
cGMP – Current Good Manufacturing Practices
RA – Regulatory Affairs
Documents
Documents specific to the preparation and QC of eCTD sequences:
- eCTD Sequence Preparation Checklist (Annexure-1)
- Technical QC Validation Report (Annexure-2)
- eCTD Submission Log (Annexure-3)
References
International Council for Harmonisation (ICH) M2 eCTD Specifications
United States Food and Drug Administration (FDA) eCTD Guidance
European Medicines Agency (EMA) eSubmission Guidelines
Company Quality Manual – Documentation and Regulatory Submissions
ISO 9001:2015 Quality Management Systems – Requirements
21 CFR Part 11 – Electronic Records; Electronic Signatures
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: eCTD Sequence Preparation Checklist
Purpose: To ensure all necessary steps and documents are prepared accurately before sequence assembly.
| Field | Details |
|---|---|
| Sequence Number | 000123 |
| Document Version | v2.1 |
| Date Prepared | 10/04/2026 |
| Modules Included | Module 1, Module 3, Module 5.3, Module 5.4 |
| Supporting Documents Verified | Yes |
| Metadata Reviewed | Yes |
| Folder Structure Confirmed | Yes |
| Preliminary TOC Generated | Yes |
| Preparer Signature | Signed electronically |
| Comments | No discrepancies noted |
Annexure-2: Technical QC Validation Report
Purpose: To document the results of technical validation and quality control checks on the eCTD sequence.
| Field | Details |
|---|---|
| Sequence Number | 000123 |
| Validation Date | 11/04/2026 |
| Validator | Regulatory QC Specialist |
| Validation Tool Used | eCTD Validator v4.5 |
| Issues Found | 0 |
| Deviation Report Raised | NA |
| Corrective Actions Taken | NA |
| Final Approval | Granted |
| Approver Signature | Signed electronically |
| Comments | All validation parameters met requirements |
Annexure-3: eCTD Submission Log
Purpose: To record details of eCTD submissions including dates, versions, recipients and acknowledgements.
| Field | Details |
|---|---|
| Sequence Number | 000123 |
| Submission Date | 12/04/2026 |
| Submission Method | Electronic via EMA eSubmission Gateway |
| Recipient Authority | European Medicines Agency |
| Submission Version | v2.1 |
| Receipt Acknowledgement | Received 12/04/2026, Ref No. EMA-2026-04567 |
| Submitted By | Regulatory Affairs Team |
| Comments | No issues reported on receipt |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 12/04/2026 | 1.0 | Initial issue | New SOP creation |