Standard Operating Procedure for Change Control in Tablet Manufacturing Processes
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/173/2025 |
| Supersedes | SOP/TAB/173/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for managing changes to tablet manufacturing processes, ensuring that all changes are properly documented, evaluated, and approved to maintain compliance with GMP and regulatory requirements.
2. Scope
This SOP applies to any changes to tablet manufacturing processes, including equipment, materials, procedures, and software used in the production of tablets.
3. Responsibilities
- Production Operator: Responsible for reporting changes that may impact the manufacturing process and ensuring that all process changes are documented correctly in the batch record.
- Quality Control (QC): Responsible for evaluating the impact of proposed changes on product quality, performing tests if necessary, and ensuring compliance with product specifications.
- Quality Assurance (QA): Ensures that change control procedures are followed, reviews change control requests, and approves changes after proper evaluation.
- Engineering/Maintenance: Responsible for implementing changes to equipment and ensuring that they meet operational and safety requirements.
4. Accountability
The Production Supervisor is accountable for ensuring that all changes to the manufacturing process are reported and documented. The QA Manager is responsible for evaluating and approving the changes.
5. Procedure
5.1 Initiating a Change Request
- Any proposed change to the tablet manufacturing process must be initiated by completing a Change Control Request Form (Annexure-1).
- The form should include details about the proposed change, such as the reason for the change, the affected process, and any anticipated impact on product quality or regulatory compliance.
- The change request must be submitted to the QA department for initial review and approval before any implementation begins.
5.2 Change Impact Assessment
- The QA team will evaluate the impact of the proposed change on product quality, safety, and compliance with regulatory standards.
- If necessary, the change will be reviewed by the relevant departments (e.g., QC, Engineering) for further evaluation, including testing and validation.
- For significant changes, a risk assessment may be conducted to determine the potential impact on the overall manufacturing process.
5.3 Approval of Change Request
- After evaluating the proposed change, the QA team will either approve or reject the change request based on the impact assessment and risk evaluation.
- For approved changes, the following actions will be taken:
- Update relevant procedures, batch records, and specifications to reflect the new process.
- Inform affected departments (e.g., Production, QC) about the change and its implementation.
- If the change involves equipment, the Engineering or Maintenance department will implement the change and ensure that the equipment is calibrated and validated, if necessary.
- Changes that involve critical processes or significant modifications must be reviewed and approved by higher management, as per the company’s approval matrix.
5.4 Implementation of Change
- Once the change is approved, the relevant departments will implement the change according to the updated procedures or specifications.
- If the change involves a manufacturing process or equipment modification, a trial run or verification process should be conducted to ensure that the change has been implemented correctly.
- The operator must follow the new process as per the updated procedures and batch records and ensure that all relevant data is documented properly in the batch record (Annexure-2).
5.5 Verification and Validation
- Following the implementation of the change, verify that the change has not impacted the product’s quality and complies with the specifications.
- If the change involves new equipment or a new material, perform validation to ensure that the change does not affect the product’s performance or safety.
- Review the results of the verification and validation tests and document them in the change control file (Annexure-3).
5.6 Documenting and Closing the Change Control
- Once the change has been implemented and verified, update all relevant documentation, including Standard Operating Procedures (SOPs), batch records, and equipment logs.
- The QA team will review the updated documentation and close the change control process, ensuring that all records are complete and accurate.
- Ensure that all employees involved in the change process are trained on the new procedures and equipment, and update training records accordingly (Annexure-4).
5.7 Change Control Documentation
- Document all change control requests, assessments, approvals, and implementation activities in the Change Control Record (Annexure-2).
- Ensure that all change control records are reviewed periodically to identify any trends or recurring issues.
- All change control records must be stored securely and in compliance with the company’s document retention policy for future reference and audits.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
7. Documents
- Change Control Request Form (Annexure-1)
- Batch Record (Annexure-2)
- Change Control Record (Annexure-3)
- Training Record (Annexure-4)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Change Control Guidelines
- ISO 9001 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Change Control Request Form
| Change Request Date | Requested By | Change Description | Impact Assessment |
|---|---|---|---|
| 01/01/2026 | John Doe | Change in tablet compression speed | Low impact on product uniformity |
Annexure-2: Change Control Record
| Change Request ID | Approved By | Implementation Date | Impact |
|---|---|---|---|
| 001 | Jane Smith | 05/01/2026 | Minimal impact on tablet quality |
Annexure-3: Preventive Action Plan
| Action | Assigned To | Due Date |
|---|---|---|
| Review and update SOP for tablet compression | John Doe | 15/01/2026 |
Annexure-4: Training Record
| Employee | Training Date | Trainer | Training Content |
|---|---|---|---|
| John Doe | 02/01/2026 | Jane Smith | Tablet Compression Process and Equipment Operation |
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 change control process | Refined approval and documentation procedures | QA Head |