Standard Operating Procedure for Module 3 Compilation and Quality Check
| Department | Regulatory Affairs |
| SOP No. | RA/2026/705 |
| Supersedes | NA |
| Page No. | 1 of X |
| Issue Date | 13/04/2026 |
| Effective Date | 13/04/2026 |
| Review Date | 13/04/2028 |
Purpose
This SOP defines the standardized process for compiling and performing a thorough quality check of Module 3 (Quality) of regulatory submissions. It ensures consistency, accuracy, and regulatory compliance of the documentation related to pharmaceutical quality, supporting timely and audit-ready dossier submissions.
Scope
This SOP applies to all activities involved in compiling and reviewing Module 3 documentation for drug products across all dosage forms and manufacturing processes. It covers cross-departmental collaboration involving Regulatory Affairs, Quality Assurance, Analytical Development, and Manufacturing. The SOP excludes non-quality-related modules and non-regulatory documentation unrelated to drug substance or drug product quality.
Responsibilities
The Regulatory Affairs team is responsible for coordinating compilation activities. Quality Assurance ensures compliance and conducts the quality check. Analytical Development and Manufacturing provide supporting data and documentation. All involved departments shall review and approve their respective contributions prior to final dossier assembly.
Accountability
The Head of Regulatory Affairs is accountable for the overall implementation, compliance, periodic review, escalation of non-conformities, and ensuring the effectiveness of this SOP within the organization.
Procedure
1. Preparation and Prerequisites:
Gather all required quality data, including drug substance and drug product specifications, manufacturing process descriptions, validation reports, stability data, and analytical method information. Confirm that all source documents have been reviewed and approved by relevant departments.
2. Compilation:
Organize Module 3 documentation following the International Council for Harmonisation (ICH) eCTD format. Ensure each section comprehensively covers required elements such as descriptions, controls, specifications, and validation outcomes. Use consistent formatting and version control throughout the dossier.
3. Safety and Compliance Checks:
Verify that all data presented comply with current regulatory guidelines and company quality standards. Confirm that any deviations or changes from prior submissions are documented and justified appropriately. Ensure all confidential or proprietary data are handled as per company policies.
4. Execution of Quality Check:
A designated QA reviewer conducts a line-by-line quality check of the compiled document for completeness, accuracy, consistency, and adherence to regulatory requirements. Cross-check references, tables, figures, and labeling information for correctness.
5. Handling Deviations and Non-conformities:
Document any discrepancies found during the quality check in deviation reports. Initiate corrective actions and ensure re-review of amended sections. Escalate critical issues to department heads promptly for resolution.
6. Approvals:
Obtain all necessary departmental reviews and approvals on the final dossier version prior to submission. Maintain a documented approval trail including dates and signatories.
7. Documentation and Record Retention:
Store final approved Module 3 dossiers and quality check records in the company’s document management system. Retain records as per regulatory and company archival policies to ensure audit readiness.
8. Closure:
After submission, monitor for any queries or assessments related to Module 3, coordinate responses as needed, and update documentation for future reference and continuous improvement.
Abbreviations
ICH – International Council for Harmonisation
QA – Quality Assurance
SOP – Standard Operating Procedure
eCTD – Electronic Common Technical Document
QA Reviewer – Quality Assurance Reviewer
Documents
These documents are specifically required for the compilation and quality checking of Module 3:
- Module 3 Compilation Checklist (Annexure-1)
- Quality Check Report for Module 3 (Annexure-2)
- Deviation Report Template for Quality Check Findings (Annexure-3)
References
ICH M4Q Guidelines (eCTD format), Company Quality System Procedures, GMP Regulations, Internal Document Control Policies, Regulatory Authority Submission Requirements.
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Module 3 Compilation Checklist
Purpose: To ensure all required sections and documents for Module 3 are compiled completely and accurately before submission.
| Section | Completed (Yes/No) | Comments |
|---|---|---|
| Drug Substance Description and Composition | Yes | Reviewed and approved |
| Manufacturing Process and Controls | Yes | Validated process included |
| Control of Materials and Specifications | Yes | All test methods referenced |
| Container Closure System | Yes | Complete stability data attached |
| Stability Data and Protocols | Yes | Data includes required time points |
| Analytical Methods Validation | Yes | Validated methods with acceptance criteria |
| Batch Analyses and Certificates of Analysis | Yes | Three recent batches included |
| Summary and Overall Quality Assessment | Yes | Consistent across all sections |
Prepared By: ____________________ Date: 13/04/2026
Reviewed By: ____________________ Date: 14/04/2026
Annexure-2: Quality Check Report for Module 3
Purpose: To document the results of the quality check performed on the Module 3 compilation.
| Check Item | Status (Pass/Fail) | Comments / Observations |
|---|---|---|
| Completeness of Documentation | Pass | All required sections included |
| Accuracy of Data Presentation | Pass | No discrepancies found |
| Compliance with Regulatory Guidelines | Pass | Aligned with ICH M4Q requirements |
| Consistency Across Sections | Pass | No conflicting information detected |
| Proper Version Control | Pass | All documents version-stamped |
| Supporting Data Reference Checks | Pass | References verified and valid |
| Formatting and Presentation | Pass | Consistent style and layout |
| Identified Deviations or Issues | None | Not applicable |
QA Reviewer: ____________________ Date: 15/04/2026
Approval: ____________________ Date: 16/04/2026
Annexure-3: Deviation Report Template for Quality Check Findings
Purpose: To document any deviations or non-conformities identified during the quality check of Module 3 and track their resolution.
| Deviation ID: | DEV-0001 |
| Date Identified: | 15/04/2026 |
| Reported By: | Quality Assurance |
| Description of Deviation: | Inconsistent specification units in drug substance section |
| Impact Assessment: | Minor – Documentation only |
| Root Cause: | Lack of version synchronization among contributors |
| Corrective Action Taken: | Revision of section and cross-check with team |
| Preventive Action Planned: | Implement stricter version control process |
| Verified By: | Quality Assurance |
| Date Closed: | 17/04/2026 |
QA Manager: ____________________ Date: 18/04/2026
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 13/04/2026 | 1.0 | Initial issue | New SOP creation |