Standard Operating Procedure for Naming Conventions for Regulatory Documents

Department	Regulatory Affairs
SOP No.	RA/2026/773
Supersedes	NA
Page No.	1 of X
Issue Date	17/04/2026
Effective Date	17/04/2026
Review Date	17/04/2028

Purpose

This Standard Operating Procedure (SOP) establishes a uniform and controlled approach for assigning names to regulatory documents within the Regulatory Affairs department. The purpose is to ensure consistency, traceability, and integrity of document identification, facilitating efficient retrieval, referencing, and compliance with regulatory requirements and internal quality standards.

Scope

This SOP applies to all regulatory documents generated, received, reviewed, stored, or archived by the Regulatory Affairs department, including but not limited to submissions, correspondence, dossiers, reports, and approvals. It covers all types of media and electronic document management systems used for regulatory documentation. This SOP excludes non-regulatory documents and documents managed by other departments under their respective nomenclature procedures.

Responsibilities

The following functional roles are responsible for executing and supporting this SOP:

• Regulatory Affairs Associate: Assigns document names following the SOP and maintains records.
• Regulatory Affairs Reviewer: Verifies adherence to naming conventions during document review.
• Regulatory Affairs Supervisor/Manager: Oversees implementation and compliance with this SOP.
• Document Control Coordinator: Ensures correct indexing and archival of named documents.
• Quality Assurance (QA): Audits and verifies compliance with the SOP during quality reviews.

Accountability

The Regulatory Affairs Department Head is accountable for ensuring effective implementation, ongoing compliance, periodic review of this SOP, escalation of issues arising from non-compliance, and coordination of training related to naming conventions for regulatory documents.

Procedure

1. Preparation and Prerequisites: Before assigning a document name, the preparer must ensure the document’s content is finalized or in the correct draft stage as per the internal review workflow. The applicable document type, version, regulatory region, and relevant identifiers must be known.

2. Naming Convention Format: All regulatory documents shall be named using the following structured format:

[Department Code]_[Document Type]_[Subject/Title Code]_[Version Number]_[Date]

Where:

• Department Code: Standard abbreviation for Regulatory Affairs (e.g., RA).
• Document Type: A predefined code indicating document category, e.g., SUB for Submission, COR for Correspondence, REP for Report.
• Subject/Title Code: Abbreviated code or brief descriptor representing the document’s subject.
• Version Number: Indicating the document version, e.g., V1.0, V2.1.
• Date: Document preparation or issue date in DDMMYYYY format.

3. Execution Steps:

1. Identify the document type and subject to assign corresponding codes accurately.
2. Assign the next sequential version number as per document control guidelines.
3. Record the document preparation or issue date in DDMMYYYY format.
4. Construct the full document name adhering to the naming format stringently.
5. Verify the naming consistency with existing similar documents to avoid duplications or conflicts.
6. Enter the named document details into the regulatory document management system for indexing and archiving.

4. Quality Checks and Verification: The reviewer shall confirm that the document name complies with the SOP naming convention before approval. Any discrepancies must be corrected before further processing.

5. Deviations and Non-Compliance: Any deviations from the established naming convention must be documented, justified, and approved by the Regulatory Affairs Supervisor or QA.

6. Record Retention: All document naming records shall be retained as per regulatory requirements and internal archive policies.

7. Closure and Review: Periodically, the Regulatory Affairs Department Head shall review naming practices for consistency and update this SOP if necessary.

Abbreviations

RA – Regulatory Affairs
SOP – Standard Operating Procedure
QA – Quality Assurance
SUB – Submission Document
COR – Correspondence Document
REP – Report Document
V – Version
DDMMYYYY – Date format (Day, Month, Year)

Documents

1. Naming Convention Code List (Annexure-1)
2. Document Naming Log Template (Annexure-2)
3. Deviation/Non-Compliance Report Form (Annexure-3)

References

1. ICH Q10 Pharmaceutical Quality System
2. EMA Guideline on Computerised Systems and Electronic Data in GMP
3. FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
4. Internal Document Control Policy
5. Good Documentation Practices (GDP) Guidelines

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Naming Convention Code List

Purpose: To provide standardized codes for departments, document types, and subject descriptors used in naming regulatory documents.

Code Type	Code	Description
Department	RA	Regulatory Affairs
Document Type	SUB	Submission Dossier
Document Type	COR	Correspondence
Document Type	REP	Report
Document Type	APP	Approval Letters
Subject Code	ND	New Drug Application
Subject Code	VAR	Variation
Subject Code	CLIN	Clinical Data
Subject Code	QA	Quality Assurance

Annexure-2: Document Naming Log Template

Purpose: To record and track regulatory document names, versions, and issue dates for traceability and control.

S.No	Document Name	Version	Issue Date	Prepared By	Remarks
1	RA_SUB_ND_V1.0_17042026	1.0	17/04/2026		Initial submission document
2	RA_COR_VAR_V1.1_15032026	1.1	15/03/2026		Variation correspondence
3	RA_REP_CLIN_V2.0_01022026	2.0	01/02/2026		Clinical study report

Annexure-3: Deviation/Non-Compliance Report Form

Purpose: To document any deviations from the naming conventions established in this SOP, including reasons and corrective actions.

Deviation Report No.	DR-RA-2026-001
Date of Deviation	05/04/2026
Document Name Involved	RA_SUB_ND_V1_04042026 (Incorrect Version Format)
Description of Deviation	The version number was recorded as “V1” instead of standard “V1.0” causing inconsistency.
Root Cause Analysis	Lack of awareness of version formatting among document preparers.
Corrective Action Taken	Training conducted on naming conventions and version control.
Preventive Action	Inclusion of version format checks in the document review checklist.
Reported By
Reviewed By
Approved By

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
17/04/2026	1.0	Initial issue	New SOP creation