Standard Operating Procedure for eCTD Submission Readiness Checklist Review
| Department | Regulatory Affairs |
| SOP No. | RA/2026/694 |
| 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) establishes a controlled and consistent methodology for conducting the eCTD submission readiness checklist review to ensure all regulatory submission components are complete, compliant, and ready for electronic submission. It aims to minimize errors, meet regulatory requirements, and support timely and accurate submissions aligned with regulatory agency expectations.
Scope
This SOP applies to all Regulatory Affairs personnel involved in preparing and reviewing electronic Common Technical Document (eCTD) submissions for pharmaceutical products. The scope covers review of dossier modules, cross-references, validation checks, document completeness, metadata accuracy, and compliance with applicable regional and global eCTD standards. This SOP excludes activities related to dossier content creation, scientific data evaluation, and post-submission regulatory correspondence.
Responsibilities
The following roles are responsible under this SOP:
- Regulatory Affairs Coordinator – Execute the checklist review, prepare documentation.
- Senior Regulatory Reviewer – Review checklist outcomes, verify compliance.
- Regulatory Manager – Supervise review process, approve checklist completion.
- Quality Assurance – Audit adherence and provide oversight.
Accountability
The Regulatory Affairs Head is accountable for ensuring implementation, compliance, timely review, escalation of issues, and periodic effectiveness evaluation of this SOP across all submission readiness activities.
Procedure
1. Preparation
Gather all dossier components intended for eCTD submission, including Module 1-5 documents, technical and administrative files, and supporting metadata files. Ensure all electronic files are accessible and stored in the predefined submission folder structure.
2. Prerequisites
Verify that the submission follows the latest regulatory dossier format and regional guidelines. Confirm completion of all upstream activities such as document finalization, approvals, and compilation according to master document control procedures.
3. Pre-Review Checks
Before starting the checklist, ensure that all file formats meet regulatory specifications (e.g., PDF/A), hyperlinks and cross-references function correctly, and filenames adhere to naming conventions. Confirm that metadata such as document IDs, version numbers, and authorship are accurate.
4. Execution Steps
Systematically review each checklist item covering:
- Completeness of dossier modules and subsections.
- Accuracy of administrative information (cover letters, forms).
- Proper sequence and structure of documents as per eCTD standards.
- Validation of hyperlinks and bookmarking within the dossier.
- Confirmation of all required certifications, declarations, and attestations.
5. In-process Controls
Flag any inconsistencies, missing documents, or deviations immediately for correction. Maintain a log of identified non-conformities with clear status updates on corrective actions taken within established timelines.
6. Verification and Acceptance Criteria
Upon completing the review, confirm that the entire checklist is fulfilled with all items marked compliant. Acceptance requires zero critical deviations and resolution of all minor issues. Obtain documented sign-off from authorized reviewers.
7. Deviations and Approvals
If any non-conformities cannot be resolved prior to submission, follow documented deviation procedures including immediate notification of the Regulatory Manager and Quality Assurance. Obtain formal approval on the deviation report before proceeding.
8. Documentation and Record Retention
Compile the completed readiness checklist, deviation reports (if any), review notes, and approval records into the submission dossier archive. Retain all records as per the company’s document retention policy and applicable regulatory requirements.
9. Closure
Confirm the readiness checklist completion status with all stakeholders. Proceed to eCTD publishing and submission activities only after obtaining formal approval of checklist review. Schedule periodic reviews of SOP effectiveness and update as needed.
Abbreviations
eCTD: electronic Common Technical Document
SOP: Standard Operating Procedure
RA: Regulatory Affairs
QA: Quality Assurance
PDF/A: Portable Document Format Archival
Documents
- eCTD Submission Readiness Checklist (Annexure-1)
- Deviation Report Form for Submission Non-Conformance (Annexure-2)
- eCTD Review Approval Form (Annexure-3)
References
International Council for Harmonisation (ICH) M2 eCTD Specifications;
FDA eCTD Guidance for Industry;
EMA eCTD Submission Standards;
Company Document Control System SOP;
Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) guidelines.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: eCTD Submission Readiness Checklist
Purpose: To systematically verify the completeness, accuracy, and compliance of the eCTD dossier prior to electronic submission.
| Checklist Item | Description | Status (Y/N) | Comments |
|---|---|---|---|
| Module 1 completeness | All regional administrative documents are present and correct. | Y | All forms completed and signed. |
| Module 2 quality overall summary | Summary document is finalized and referenced correctly. | Y | No discrepancies noted. |
| Module 3 quality, nonclinical, clinical sections | All technical documents included, cross-referenced, and coherent. | Y | Validated hyperlinks functional. |
| File naming convention | All files follow company and regulatory naming standards. | Y | Checked by document control. |
| Hyperlinks and bookmarks | All links are active and correctly mapped. | Y | No broken links found. |
| Metadata accuracy | Document IDs, versions, and authorship checked. | Y | Metadata consistent across files. |
| PDF/A compliance | All documents saved in required format. | Y | Verified Adobe Acrobat compliance report attached. |
| Certifications and attestations | All required certificates and declarations present. | Y | Signed and dated as per guidelines. |
Annexure-2: Deviation Report Form for Submission Non-Conformance
Purpose: To document any deviations identified during the eCTD readiness review and track their resolution prior to submission.
| Deviation Report No. | DR-2026-005 |
| Date of Deviation: | 10/04/2026 |
| Reported By: | Regulatory Coordination Team |
| Description of Deviation: | Missing signature on Module 1 cover letter. |
| Impact Assessment: | No impact on clinical data; delays final submission sign-off. |
| Corrective Action Taken: | Cover letter re-signed and re-uploaded to submission folder. |
| Approval of Deviation Resolution: | Approved by Regulatory Manager on 11/04/2026 |
| Remarks: | Deviation closed and checklist updated accordingly. |
| Signatures: | Regulatory Manager / Quality Assurance |
Annexure-3: eCTD Review Approval Form
Purpose: To document final approval and authorization of the eCTD submission readiness checklist review prior to dossier publishing and dispatch.
| Document Number: | RA/2026/694-APPROVAL |
| Reviewed By: | Senior Regulatory Reviewer |
| Review Date: | 12/04/2026 |
| Approval By: | Regulatory Manager |
| Approval Date: | 12/04/2026 |
| Comments: | All checklist requirements satisfactorily met. Ready for submission. |
| Signatures: | Reviewer / Approver |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 12/04/2026 | 1.0 | Initial issue | New SOP creation |