Standard Operating Procedure for Technical Review of Drug Substance and Drug Product Sections

Department	Regulatory Affairs
SOP No.	RA/2026/715
Supersedes	NA
Page No.	1 of X
Issue Date	13/04/2026
Effective Date	13/04/2026
Review Date	13/04/2028

Purpose

This Standard Operating Procedure (SOP) defines the systematic approach and control measures for the comprehensive technical review of Drug Substance and Drug Product sections within regulatory submissions and dossier documentation. The objective is to ensure accuracy, compliance with regulatory guidelines, scientific soundness, and completeness of information prior to submission or internal approvals, thereby supporting regulatory compliance and facilitating timely approval processes.

Scope

This SOP applies to all technical review activities related to Drug Substance and Drug Product sections of regulatory dossiers, including Chemistry, Manufacturing, and Controls (CMC) documentation. It encompasses review of data, supporting documents, analytical methods, stability information, manufacturing processes, and quality attributes prepared by cross-functional departments. The scope covers both investigational and commercial products in all dosage forms. Activities outside of dossier technical review, such as administrative processing or submission logistics, are excluded.

Responsibilities

The following functional roles are involved:

• Regulatory Affairs Reviewer – executes detailed technical review and identifies gaps.
• Subject Matter Experts (e.g., Quality, Manufacturing, Analytical Development) – provide technical input and clarifications.
• Regulatory Affairs Supervisor – oversees the review process and ensures adherence to SOP timelines.
• Quality Assurance – verifies compliance to established quality standards and procedures.
• Documentation Control – manages document versioning, archiving, and distribution of reviewed dossiers.

Accountability

The Regulatory Affairs Head is accountable for overall implementation, periodic review, escalation of issues, ensuring compliance with this SOP, and conducting effectiveness assessments to maintain high-quality regulatory documentation standards.

Procedure

The technical review of Drug Substance and Drug Product sections must be performed following a structured and systematic procedure as outlined below. This ensures thorough verification of content accuracy, regulatory compliance, and scientific integrity:

1. Preparation and Prerequisites
Prior to initiating review, the Regulatory Affairs Reviewer shall ensure receipt of the complete dossier package, including all related analytical, manufacturing, and stability data. Necessary training on current regulatory guidelines and company policies must be current. Access to relevant pharmacopeial and regulatory references should be confirmed.

2. Initial Assessment
Conduct an initial scan to verify the completeness of the sections and the presence of applicable annexures, certificates, and reports. Confirm alignment of data with the intended submission type (e.g., NDA, ANDA, MAA). Identify critical points and potential high-risk areas for focused review.

3. Detailed Technical Review
Examine product description, composition, manufacturing process parameters, control strategy, analytical methods, validation reports, stability data, and batch analysis results. Assess consistency and correlation among data sets. Verify compliance with applicable regulatory standards, pharmacopeial limits, and internal quality specifications. Investigate any anomalies or deviations reported, requesting clarifications from cross-functional teams as needed.

4. Verification of Documentation and Formatting
Check that all documents are appropriately formatted, properly referenced, dated, and signed as per company and regulatory requirements. Confirm version control is maintained throughout the dossier.

5. In-Process Reviews and Reviews Meetings
Participate in review meetings with relevant departments to discuss findings, resolve queries, and align on necessary corrections or additional data requirements. Document outcomes of these discussions.

6. Approval and Reporting
Upon satisfactory completion, the Regulatory Affairs Reviewer prepares a summarized review report indicating findings, suggested corrections, and confirmation of compliance. Submit the report to the Regulatory Affairs Supervisor for approval before dossier finalization.

7. Handling Deviations and Non-Conformities
If significant deviations or non-compliant data are identified, record and escalate these findings through the appropriate quality management channels, initiating corrective and preventive actions (CAPA) as necessary.

8. Documentation and Record Retention
Maintain all review records, correspondence, and approvals within the document control system in accordance with company record retention policies. Ensure confidentiality and restrict access to authorized personnel only.

This procedural approach ensures that all technical reviews are thorough, compliant, and traceable, supporting quality regulatory submissions and minimizing risk of approval delays.

Abbreviations

• CMC – Chemistry, Manufacturing, and Controls
• NDA – New Drug Application
• ANDA – Abbreviated New Drug Application
• MAA – Marketing Authorization Application
• GMP – Good Manufacturing Practice
• CAPA – Corrective and Preventive Action
• SOP – Standard Operating Procedure

Documents

Documents required specific to this SOP are:

1. Technical Review Checklist for Drug Substance and Drug Product (Annexure-1)
2. Dossier Review Summary Report Template (Annexure-2)
3. Deviation and CAPA Log for Regulatory Review (Annexure-3)

References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Content and Format of the Chemistry, Manufacturing, and Controls Section of an Application
• EU Guidelines on Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
• Internal Quality Management System Documentation
• Relevant Pharmacopoeial Monographs (USP, Ph.Eur.)

Version

1.0

Approval

Prepared By
Checked By
Approved By

Annexures

Annexure-1: Technical Review Checklist for Drug Substance and Drug Product

Purpose: This checklist is designed to guide and document the systematic technical review of the Drug Substance and Drug Product sections within regulatory dossiers.

Section	Review Item	Status (Yes/No)	Comments
1. Product Description	Is the composition correctly specified?	Yes	All components listed with correct percentages.
2. Manufacturing Process	Is the process flow adequately described?	Yes	Includes key parameters and critical control points.
3. Analytical Methods	Methods are validated and referenced?	Yes	Validation reports provided.
4. Stability Data	Data supports proposed shelf life?	Yes	Stability studies cover required conditions.
5. Batch Analysis Report	Results comply with specifications?	Yes	No out-of-specification results noted.
6. Documentation	All documents are properly signed and dated?	Yes	Version control maintained.

Annexure-2: Dossier Review Summary Report Template

Purpose: This report summarizes the outcome of the technical review for the Drug Substance and Drug Product dossier sections.

Product Name:	Example Product XYZ
Dosage Form:	Tablet
Review Period:	01/03/2026 to 10/03/2026
Reviewer:	[Reviewer ID]
Summary of Findings:	All sections met required standards except minor clarification needed on analytical method validation protocols.
Recommendations:	Request updated validation reports and confirm batch release criteria compliance.
Approval Status:	Pending supervisory review

Annexure-3: Deviation and CAPA Log for Regulatory Review

Purpose: To document any deviations found during the technical review process and the corrective and preventive actions taken.

Deviation No.	Date Identified	Description	Root Cause	Corrective Action	Preventive Action	Status
DEV-001	05/03/2026	Analytical validation document outdated	Revised protocol not incorporated in dossier	Request updated documents from Analytical team	Review document control process for updates	Closed
DEV-002	07/03/2026	Inconsistent batch numbering in stability data	Data transcription error	Cross-verify data entries with laboratory records	Implement double-check process for data entry	Open

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
13/04/2026	1.0	Initial issue	New SOP creation