Standard Operating Procedure for Automated In-Process Data Review Systems
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/153/2025 |
| Supersedes | SOP/TAB/153/2022 |
| 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 using automated in-process data review systems to monitor and review tablet manufacturing processes in real-time, ensuring data integrity and compliance with GMP standards.
2. Scope
This SOP applies to the use of automated data review systems for in-process monitoring during tablet manufacturing, including data related to weight, hardness, moisture content, and other critical process parameters.
3. Responsibilities
- Quality Control (QC): Responsible for configuring, monitoring, and reviewing automated data review systems for compliance with predefined specifications.
- Production Operator: Ensures that in-process data is captured in the automated systems and reports any deviations or alerts to QC.
- Quality Assurance (QA): Ensures the review system is functioning as per the SOP and that any issues are addressed through corrective actions and validation.
4. Accountability
The QC Manager is accountable for ensuring the effective use of the automated in-process data review system. The QA Manager ensures the validation and compliance of the system with regulatory requirements.
5. Procedure
5.1 System Configuration
- Ensure that the automated system is correctly configured to capture relevant process data such as tablet weight, hardness, moisture content, and other critical parameters during manufacturing.
- Set up appropriate alarm thresholds for each parameter, including upper and lower limits, based on product specifications and regulatory guidelines.
- Verify that all sensors, controllers, and data collection points are properly integrated with the system.
5.2 Data Capture
- Ensure that the automated system continuously captures in-process data from the production line during tablet manufacturing.
- Verify that data is recorded at regular intervals and is consistent with the predefined parameters for each tablet batch.
- Check that the system logs any relevant events or changes in process conditions for further review.
5.3 Real-Time Monitoring and Alerts
- Monitor the real-time data through the automated system interface to ensure that all parameters are within the acceptable range.
- If any data point falls outside the predefined threshold, the system should trigger an automatic alert to notify the relevant personnel (QC, production operator, etc.)
- Investigate any alerts immediately and determine if corrective actions are necessary to maintain process consistency.
5.4 Data Review and Documentation
- Review the data collected by the automated system at the end of each production run to ensure it meets quality and process specifications.
- Document any findings, deviations, or corrective actions taken in the batch record (Annexure-2).
- Review data trends and compare them with historical data to identify any potential issues that may need further investigation.
5.5 Corrective Actions
- If a process parameter is found to be out of specification or if an alert is triggered, initiate corrective actions as appropriate.
- Adjust machine settings, calibrate equipment, or modify process conditions to bring the parameter back within the acceptable range.
- Document all corrective actions taken and monitor the system to verify the effectiveness of the actions.
5.6 Validation and Calibration
- Ensure that the automated data review system is validated before use, following the equipment qualification and validation procedures outlined in SOP/TAB/101/2025 (Equipment Qualification).
- Calibrate all measurement devices and sensors connected to the system regularly to maintain accuracy and precision.
- Perform revalidation of the system after any significant system upgrades or changes in the manufacturing process.
5.7 Post-Inspection Actions
- After the review and necessary corrective actions, finalize the batch record and approve the data for further manufacturing steps such as packaging and labeling.
- If the system identifies any recurrent issues, perform a detailed investigation to assess the root cause and take necessary actions to prevent recurrence.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CAPA: Corrective and Preventive Actions
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
- Calibration Log (Annexure-3)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- USP <701> – General Guidelines for Equipment and Instrumentation in Pharmaceutical Manufacturing
- ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Moisture content out of specification | Adjusted drying parameters and recalibrated moisture analyzer | John Doe |
Annexure-2: Batch Record
| Sample Number | Process Parameter | Recorded Value | Action Taken |
|---|---|---|---|
| Sample 1 | Weight | 100 mg | Accepted |
Annexure-3: Calibration Log
| Device ID | Calibration Date | Calibration Method | Result |
|---|---|---|---|
| Sensor-01 | 15/12/2025 | Standard calibration | Passed |
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 | Improved automated data review system | Enhanced system accuracy and reliability | QA Head |