Standard Operating Procedure for Dossier Control of Batch Data and Manufacturing Records
| Department | Regulatory Affairs |
| SOP No. | RA/2026/714 |
| 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) establishes a uniform and controlled approach for the management, maintenance, and verification of dossier records containing batch data and manufacturing records. The objective is to ensure the accuracy, completeness, confidentiality, and traceability of the dossiers to support regulatory submission readiness, compliance with good manufacturing practices (GMP), and audit preparedness.
Scope
This SOP applies to all regulatory affairs and related functional areas responsible for managing batch data and manufacturing records dossiers. It covers all dosage forms, processes, equipment records, validation documents, and manufacturing site records used in dossier compilation. This SOP excludes records maintained solely for internal use that do not form part of the regulatory submission dossiers.
Responsibilities
- Regulatory Affairs Personnel: Responsible for compiling, reviewing, and maintaining dossier documentation as per regulatory requirements.
- Quality Assurance (QA): Responsible for ensuring dossier integrity through review and approval processes.
- Manufacturing and Operations Staff: Provide accurate batch and manufacturing data to be included in dossiers.
- Document Control Department: Responsible for version control, storage, and distribution of dossiers.
- Supervisors and Managers: Oversee adherence to this SOP within their departments.
Accountability
The Head of Regulatory Affairs holds primary accountability for the implementation, compliance monitoring, periodic review, and continuous improvement of this SOP. Escalations related to deviations or non-compliance shall be directed to this role.
Procedure
The dossier control procedure involves systematic stages to ensure complete, accurate, and compliant management of batch data and manufacturing records:
1. Preparation and Prerequisites: Verify that all batch data and manufacturing records are complete, signed, and verified by authorized personnel prior to dossier compilation. Ensure that all supporting documents such as validation, calibration, and equipment records relevant to the batch are available.
2. Document Collection and Compilation: Collect all validated batch data, manufacturing instructions, test results, deviation reports, and related annexures. Compile these documents systematically following a predetermined dossier structure aligned with regulatory guidelines.
3. Document Review and Verification: Regulatory Affairs personnel perform a thorough review for completeness, accuracy, and consistency. Cross-verify data entries with original records and any electronic systems used. Ensure that deviations and non-conformities are documented with appropriate justifications.
4. Version Control and Approval: Utilize document control systems to assign version numbers and control the distribution of dossier versions. Obtain required approvals from QA and regulatory supervisors. Maintain an approval log as part of the dossier.
5. Storage and Accessibility: Store dossiers securely in an access-controlled environment, whether physical or electronic, to prevent unauthorized alterations or loss. Ensure backup copies are available in line with organizational policies.
6. Periodic Review and Updates: Conduct periodic dossier reviews to ensure that information remains accurate and relevant. Update dossiers as necessary to reflect any process changes, regulatory updates, or validation requalification results.
7. Handling Deviations and Non-Conformities: Document any deviations in dossier preparation or discrepancies in batch data. Initiate corrective and preventive actions (CAPA) and document the resolution process. Approval of changes or deviations must be obtained prior to dossier finalization.
8. Documentation and Record Retention: Maintain all documents in compliance with GMP and regulatory requirements, with clear traceability and audit trails. Records should be retained for the period specified by relevant regulations or company policy.
9. Dossier Submission and Audit Readiness: When dossiers are submitted to regulatory authorities, confirm that the compilation is current and fully compliant. Prepare for audit or inspection by ensuring immediate access and retrieval capability for dossier documents.
This procedure ensures a controlled, compliant, and auditable approach to dossier management, fostering regulatory confidence and organizational compliance.
Abbreviations
- GMP – Good Manufacturing Practice
- QA – Quality Assurance
- CAPA – Corrective and Preventive Action
- DMS – Document Management System
- RA – Regulatory Affairs
Documents
The following documents are required to execute the dossier control process effectively:
- Batch Data Compilation Checklist (Annexure-1)
- Dossier Review and Verification Log (Annexure-2)
- Dossier Approval Form (Annexure-3)
References
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- 21 CFR Parts 210 & 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- EU GMP Annex 11 – Computerised Systems
- International Standard ISO 9001:2015 – Quality Management Systems
- Company Document Control Policy and Procedures
Version
1.0
Approval
| Prepared By | |
| Checked By | |
| Approved By |
Annexures
Annexure-1: Batch Data Compilation Checklist
Purpose: To ensure all required batch data and manufacturing records are collected and included in the dossier in a complete and organized manner.
| Field | Description / Example |
|---|---|
| Batch Number | BN-2026-045 |
| Dosage Form | Tablet |
| Manufacturing Date | 01/04/2026 |
| Collected Documents | Batch Manufacturing Record, In-process Control Data, Equipment Logbooks |
| Validation Reports Included | Yes |
| Calibration Certificates Included | Yes |
| Deviations Documented | No |
| Checklist Completed By | |
| Date | 10/04/2026 |
| Remarks | All documents verified for inclusion |
Annexure-2: Dossier Review and Verification Log
Purpose: To record detailed review and verification actions performed on dossier contents ensuring completeness and regulatory compliance.
| Field | Description / Example |
|---|---|
| Dossier Version | V1.0 |
| Reviewed By | |
| Review Date | 11/04/2026 |
| Verification Points | Completeness of batch records, accuracy of test data, signature verification |
| Findings | All sections complete; no discrepancies found |
| Corrective Actions | Not applicable |
| Review Comments | Dossier ready for approval |
Annexure-3: Dossier Approval Form
Purpose: To formally document the approval of dossier compilation and readiness for regulatory submission or internal distribution.
| Field | Description / Example |
|---|---|
| Dossier Title | Batch Data and Manufacturing Records for Product XYZ |
| Dossier No. | RA-DOC-2026-045 |
| Version | 1.0 |
| Approved By | |
| Approval Date | 12/04/2026 |
| Comments | Approved as per SOP requirements |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
| 13/04/2026 | 1.0 | Initial issue | New SOP creation |