Standard Operating Procedure for Documentation Control in Tablet Manufacturing Units
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/175/2025 |
| Supersedes | SOP/TAB/175/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To establish procedures for the control and management of documentation in tablet manufacturing units, ensuring compliance with regulatory requirements and Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all documentation related to tablet manufacturing processes, including batch records, SOPs, training records, and equipment logs within the tablet manufacturing unit.
3. Responsibilities
- Quality Assurance (QA): Responsible for overseeing the document control system, ensuring that all documentation is properly created, reviewed, approved, and maintained in compliance with GMP standards.
- Production Supervisors: Responsible for ensuring that all personnel follow the correct procedures for document handling, including document preparation, review, and approval.
- Document Control Officer: Responsible for managing the storage, distribution, and retrieval of all controlled documents in the tablet manufacturing unit.
- All Personnel: Responsible for using only the most recent and approved versions of controlled documents during the manufacturing process.
4. Accountability
The QA Manager is responsible for ensuring that all documentation is controlled according to the company’s document control procedures. The Document Control Officer is responsible for maintaining and ensuring the availability of updated documents.
5. Procedure
5.1 Document Creation and Review
- All new documents (e.g., SOPs, batch records, log sheets) must be created in accordance with the company’s template and format guidelines.
- Documents must be reviewed by relevant department heads and subject matter experts (SMEs) for accuracy, compliance with GMP, and regulatory requirements.
- The document must be reviewed and approved by QA before it can be finalized and distributed for use in the tablet manufacturing unit.
- Document drafts and final versions must be marked with version numbers, review dates, and approval signatures (Annexure-1).
5.2 Document Approval and Distribution
- Once approved, the document is assigned a unique document number and is stored in the company’s central document management system (DMS) for easy access.
- Approved documents must be made available to all relevant personnel. A controlled distribution list must be maintained to track which employees have access to each document version.
- Old versions of documents must be removed from circulation and replaced with the updated versions. Ensure that all outdated documents are archived or destroyed as appropriate.
5.3 Document Retrieval and Access
- Documents must be easily accessible to authorized personnel for reference, review, or training purposes.
- Access to controlled documents must be restricted to authorized individuals, and a log must be maintained to track who accessed each document (Annexure-2).
- Documents must be stored in a secure, organized manner to prevent loss or damage and to ensure easy retrieval for audits and inspections.
5.4 Document Revision and Update
- Whenever a document is revised or updated, the revised version must be reviewed and approved according to the same procedure as the original document.
- When a document is updated, the version number, revision date, and the reason for the revision must be clearly indicated on the document (Annexure-3).
- Ensure that personnel are trained on the updated document and informed of any significant changes to procedures or processes.
5.5 Document Archiving and Retention
- Once a document is obsolete or no longer in use, it must be archived or destroyed in accordance with the company’s record retention policy.
- Documents must be retained for the required period, based on the regulatory guidelines and the company’s document retention policy.
- Archived documents must be stored securely and be retrievable for audits, inspections, or regulatory reviews.
5.6 Document Audits and Reviews
- Regular audits of controlled documents should be conducted to ensure compliance with GMP and regulatory standards.
- The QA team will review the effectiveness of the document control system annually and make improvements as necessary to enhance the process.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- DMS: Document Management System
7. Documents
- Document Control Log (Annexure-1)
- Access Log (Annexure-2)
- Document Revision Log (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- European Pharmacopoeia (EP) – Documentation and Record-Keeping Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Document Control Log
| Document Number | Version | Effective Date | Reviewed By | Approval Date |
|---|---|---|---|---|
| SOP/TAB/001 | 1.0 | 01/03/2025 | John Doe | 01/03/2025 |
Annexure-2: Document Access Log
| Document Number | Employee Name | Access Date | Signature |
|---|---|---|---|
| SOP/TAB/001 | John Doe | 02/03/2025 | Signature |
Annexure-3: Document Revision Log
| Revision Date | Version | Revision Details | Approved By |
|---|---|---|---|
| 01/01/2025 | 1.0 | Initial Version | QA Head |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated document control procedures | Standardized document handling and access | QA Head |