Standard Operating Procedure for Real-Time Data Logging in In-Process Monitoring
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/142/2025 |
| Supersedes | SOP/TAB/142/2022 |
| 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 real-time data logging during in-process monitoring of tablet manufacturing to ensure accurate recording, traceability, and compliance with production specifications.
2. Scope
This SOP applies to the real-time logging of manufacturing data during tablet production processes, such as compression, coating, and drying, to ensure consistent product quality and process control.
3. Responsibilities
- Quality Control (QC): Responsible for monitoring and logging in-process data and ensuring data integrity.
- Production Operator: Responsible for entering process data into the logging system as per the defined procedure and assisting in real-time monitoring of process parameters.
- Quality Assurance (QA): Reviews data logs to verify compliance with specifications and ensures that any deviations are investigated and addressed.
4. Accountability
The QC Manager is accountable for ensuring that data logging is conducted in real time and accurately recorded during all critical in-process activities. The QA Manager is responsible for reviewing and approving the logged data for compliance with quality standards.
5. Procedure
5.1 Setup and Configuration of Data Logging System
- Ensure that the data logging system is set up and configured to collect relevant parameters for the tablet manufacturing process, including temperature, pressure, weight, and humidity, depending on the specific process step.
- Verify that the system is calibrated and that all sensors and instruments connected to the data logging system are functioning correctly before starting the production batch.
- Set the required data logging intervals (e.g., every minute or batch cycle) to ensure accurate real-time data collection.
- Assign specific team members to monitor and verify the system during the batch production to ensure that data is being logged correctly.
5.2 Data Logging During Tablet Manufacturing
- Start the data logging system at the beginning of the manufacturing process, ensuring that the parameters are being captured from the moment production begins.
- Monitor the in-process data in real time, ensuring that the logged values remain within the established specifications (e.g., tablet weight during compression, temperature during coating, humidity during drying).
- At regular intervals, ensure that the data is recorded without interruptions and that the system is capturing relevant data accurately.
- If a process deviation occurs (e.g., temperature exceeds the set limit during coating), pause production, investigate the root cause, and document the issue in the deviation log (Annexure-1). Corrective actions should be implemented before continuing the process.
5.3 Real-Time Monitoring and Alerts
- Ensure that the data logging system is equipped with real-time alerts for any out-of-specification (OOS) values. These alerts should notify the operator or QC personnel immediately if any monitored parameter goes beyond the defined acceptable limits.
- When an alert is triggered, stop the production process, identify the source of the issue, and take corrective actions to bring the process back within specification.
- Record all deviations and corrective actions in the batch record (Annexure-2) and the deviation report (Annexure-1).
5.4 Data Storage and Backup
- Ensure that the data collected during the process is stored in a secure and backed-up location. This data must be retrievable for future review, audits, or regulatory inspections.
- Data should be stored for a minimum period defined by company policy or regulatory requirements, ensuring that all records are traceable and accessible.
- Perform routine data backups to prevent data loss. Ensure that backup data is stored in a secure and controlled environment to protect the integrity and confidentiality of the information.
5.5 Documentation and Review
- Document all process parameters and logged data, including any deviations and corrective actions taken, in the batch record (Annexure-2).
- Ensure that the data log is reviewed periodically by QA personnel to verify that all process parameters remain within acceptable limits and that corrective actions are appropriately documented.
- If any discrepancies are found, investigate and resolve the issue immediately, documenting any changes made to the process in the deviation report (Annexure-1).
5.6 Acceptance Criteria
- The logged data must fall within the predefined acceptable ranges for all critical process parameters.
- If any process parameter exceeds the specified limits, corrective actions must be taken, and the batch may need to be reprocessed or rejected if it fails to meet quality standards.
5.7 Post-Process Actions
- Once the batch is complete and all data has been logged, review the data log for accuracy and completeness. Ensure that all parameters were monitored according to the SOP.
- Ensure that the data log is archived as part of the batch record for future reference and audit purposes.
- Complete any necessary reports based on the logged data and submit them for final review and approval by QA personnel.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- OOS: Out of Specification
7. Documents
- Batch Record (Annexure-2)
- Deviation Report (Annexure-1)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- USP <1058> – In-Process Monitoring and Data Logging
- European Pharmacopoeia (EP) – Data Integrity and Logging for Manufacturing Processes
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 | Temperature exceeded 30°C during coating | Adjusted spray rate and temperature control | John Doe |
Annexure-2: Batch Record
| Sample Number | Process Parameter | Logged Value | Action Taken |
|---|---|---|---|
| Sample 1 | Tablet Weight | 500 mg | Accepted |
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 real-time monitoring process | Improved process monitoring | QA Head |