Standard Operating Procedure for Hyperlinking Bookmarking and Publishing Quality Checks
| Department | Regulatory Affairs |
| SOP No. | RA/2026/687 |
| 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 quality checks required for hyperlinking, bookmarking, and publishing activities within electronic Common Technical Document (eCTD) submissions. The purpose is to ensure accuracy, consistency, and compliance with regulatory guidelines throughout the eCTD compilation and submission processes, thereby supporting reliable regulatory submissions and preventing errors that could lead to submission delays or regulatory noncompliance.
Scope
This SOP applies to all hyperlinking, bookmarking, and publishing operations conducted on eCTD submissions within the Regulatory Affairs department. It covers electronic document quality checks related to hyperlink accuracy, bookmark functionality, and final document publishing prior to submission. This includes all types of regulatory submissions intended for Health Authorities worldwide. Activities outside eCTD submission compilation, such as regulatory correspondence management or paper-based submissions, are excluded.
Responsibilities
- Regulatory Affairs Specialists: Execute hyperlinking, bookmarking, and publishing tasks and perform initial quality checks.
- QA Reviewers: Review the compiled eCTD submission for compliance with checklist criteria and confirm quality of hyperlinks and bookmarks.
- Regulatory Leads/Managers: Supervise the publication workflow and authorize final submission packaging.
- Documentation Control: Maintain version control and archive all finalized submission packages.
Accountability
The Regulatory Affairs Head is accountable for the overall implementation, adherence, and periodic review of this SOP. This role ensures that escalation paths are followed for deviations and that the SOP remains effective through scheduled audits and updates.
Procedure
The quality check procedure for hyperlinking, bookmarking, and publishing within eCTD submissions consists of the following stages:
1. Preparation and Prerequisites: Verify that all source documents intended for eCTD compilation are complete, approved, and in the correct format (PDF/A or as specified). Confirm the submission scope and target authority requirements.
2. Hyperlinking Checks: – Insert hyperlinks according to the eCTD structure, ensuring logical navigation pathways between modules and documents. – Validate each hyperlink by clicking through and confirming it navigates to the correct destination without errors or latency. – Validate internal and external links, and ensure no broken or dead links are present. Record any discrepancies for correction.
3. Bookmarking Checks: – Create bookmarks reflecting the hierarchical structure of the submission for ease of navigation. – Confirm that bookmarks open the intended document pages. – Validate bookmark naming conventions align with regulatory standards and SOP guidelines.
4. Publishing Preparation: – Compile the fully linked and bookmarked documents into the final eCTD submission package. – Perform file naming and numbering compliance checks in accordance with regional specifications.
5. Quality Control Review: – QA personnel perform a thorough review based on the established checklist covering hyperlink and bookmark integrity, document formatting, and metadata accuracy. – Any nonconformities are documented and returned for remediation before re-verification.
6. Approvals and Finalization: – Upon satisfactory review, obtain sign-off from regulatory leads authorizing the final published package. – Ensure all signoffs are documented in accordance with internal requirements.
7. Documentation and Record Retention: – Archive the final published submission package along with reviewed quality checklists and sign-off records in the controlled document management system. – Maintain retention per internal document control and regulatory compliance timelines.
8. Deviations and Escalations: – Any deviations or errors encountered during hyperlinking, bookmarking, or publishing steps must be logged using the defined nonconformance process and escalated to the Regulatory Affairs Head. – Implement corrective and preventive actions as necessary.
This procedure ensures that all hyperlinking, bookmarking, and publishing activities are executed consistently and conform to regulatory expectations, thereby minimizing risks of submission errors and ensuring quality eCTD management.
Abbreviations
- eCTD: electronic Common Technical Document
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- PDF/A: Portable Document Format Archive
- GMP: Good Manufacturing Practice
Documents
- Hyperlinking and Bookmarking Quality Checklist (Annexure-1)
- eCTD Submission Packaging and Publishing Log (Annexure-2)
- Deviation Report Form for eCTD Publishing (Annexure-3)
References
- ICH M2 Electronic Common Technical Document Specifications
- EMA Guideline on eSubmission
- FDA eCTD Guidance for Industry
- Internal Quality Management System Documentation Control Procedure
- GMP Compliance Requirements for Regulatory Submissions
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Hyperlinking and Bookmarking Quality Checklist
| Field | Description / Example |
|---|---|
| Checklist ID | HYP-BMK-CHK-001 |
| Date | 12/04/2026 |
| Prepared By (Initials) | R.A.S. |
| Document Name / Module | Module 2 – CTD Table of Contents |
| Hyperlink Verification | All hyperlinks tested and confirmed functional |
| Bookmark Verification | Bookmarks correctly reflect document hierarchy and pages |
| File Format Verification | PDF/A compliant |
| Discrepancies Found | None |
| Reviewer Comments | N/A |
| Reviewer Signature | __________ |
| Date Reviewed | 13/04/2026 |
Annexure-2: eCTD Submission Packaging and Publishing Log
| Field | Description / Example |
|---|---|
| Submission ID | SUB-2026-045 |
| Compilation Date | 12/04/2026 |
| Compiled By | R.A.S. |
| Publishing Date | 13/04/2026 |
| Publisher | R.A.S. |
| Final Review Status | Approved |
| Approver | Regulatory Lead |
| Comments | All bookmarks and hyperlinks verified and approved |
| Signatures | __________________ |
Annexure-3: Deviation Report Form for eCTD Publishing
| Field | Description / Example |
|---|---|
| Deviation ID | DEV-2026-011 |
| Date of Deviation | 12/04/2026 |
| Reported By | R.A.S. |
| Description of Issue | Broken hyperlinks detected in Module 3 documents |
| Immediate Actions Taken | Hyperlinks corrected and retested |
| Root Cause Analysis | Incorrect link source files used during compilation |
| Corrective Action | Staff training on source file management |
| Preventive Action | Implementation of checklist for source document validation |
| Reviewer | QA Reviewer |
| Approval | Regulatory Affairs Head |
| Signatures | __________________ |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 12/04/2026 | 1.0 | Initial issue | New SOP creation |