Tablets: SOP for Real-Time Process Monitoring using PAT Tools – V 2.0

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Tablets: SOP for Real-Time Process Monitoring using PAT Tools – V 2.0

Standard Operating Procedure for Real-Time Process Monitoring using PAT Tools

Department Tablet
SOP No. SOP/TAB/058/2025
Supersedes SOP/TAB/058/2022
Page No. Page 1 of 7
Issue Date 30/11/2025
Effective Date 05/12/2025
Review Date 30/11/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for utilizing Process Analytical Technology (PAT) tools for real-time monitoring of the tablet manufacturing process. The goal is to enhance process control, improve product quality, and ensure consistent production of tablets by continuously monitoring key parameters.

2. Scope

This SOP applies to all tablet manufacturing processes that utilize PAT tools for real-time process monitoring. It covers the setup, operation, and maintenance of PAT tools during tablet production, as well as the interpretation of data to optimize the manufacturing process.

3. Responsibilities

  • Manufacturing Personnel: Responsible for operating the tablet press and ensuring that PAT tools are properly calibrated and used for real-time monitoring of the manufacturing process.
  • Quality Control (QC): Responsible for analyzing the data from PAT tools, ensuring that the real-time monitoring parameters meet the required specifications, and performing in-process testing as necessary.
  • Quality Assurance (QA): Ensures that the PAT monitoring system is compliant with the SOP, reviews process data, and approves any changes to the tablet manufacturing process based on real-time monitoring insights.
  • Maintenance Personnel: Responsible for ensuring that PAT tools are maintained, calibrated, and functioning correctly according to the manufacturer’s specifications and the preventive maintenance schedule.

4. Accountability

The Production Manager is accountable for ensuring that real-time monitoring using PAT tools is integrated into the tablet manufacturing process. The QA Manager ensures the data is properly reviewed and that the process remains compliant with GMP standards.

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5. Procedure

5.1 Pre-Production Setup of PAT Tools

  1. Ensure that the PAT tools are calibrated according to the manufacturer’s specifications before the start of production. Verify that all sensors, probes, and monitoring systems are functioning properly.
  2. Set up the PAT system to monitor critical process parameters such as tablet weight, hardness, thickness, and powder flow rate in real-time.
  3. Confirm that the system is connected to the tablet compression machine and is actively collecting and analyzing data during the production process.
  4. Review the process parameters that will be monitored and ensure they are aligned with the specifications in the batch record.
  5. Ensure that all PAT data is being logged and stored in the appropriate database for traceability and regulatory compliance.

5.2 Real-Time Monitoring during Tablet Compression

  1. Start the tablet compression process and monitor key parameters in real time using the PAT system, including compression force, tablet weight, hardness, and thickness.
  2. Set acceptable ranges for each parameter based on the batch specifications. The system will provide alerts if any parameter falls outside the specified range.
  3. Continuously monitor and compare the real-time data against the established control limits. Any deviations should trigger an immediate review by the operator or the QC team.
  4. If an out-of-specification (OOS) condition is detected, stop the process, investigate the cause, and take corrective actions. Possible actions may include adjusting the compression force, material feed rate, or tooling condition.
  5. Document all real-time data in the batch record (Annexure-1) and any corrective actions taken. The system should automatically log the data, but manual verification is required for accuracy.

5.3 Data Interpretation and Decision Making

  1. Analyze the real-time data provided by the PAT tools to identify trends or issues that may require adjustments in the manufacturing process.
  2. Use the PAT data to predict potential process deviations before they occur, allowing for early intervention and process optimization.
  3. If significant deviations are detected, determine the root cause by reviewing the historical and real-time data. Possible causes include:
    • Improper tool alignment
    • Material inconsistencies
    • Changes in environmental conditions
  4. Make necessary adjustments to the tablet compression parameters and document the actions in the batch record (Annexure-1).
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5.4 Post-Production Review of PAT Data

  1. After completing the production run, perform a final review of the PAT data to verify that all process parameters were within specification.
  2. Ensure that the final tablet quality checks, such as tablet weight, hardness, and appearance, align with the real-time monitoring data.
  3. If any data indicates potential quality concerns, perform further testing and investigate possible causes (e.g., batch variations, equipment issues).
  4. Document the post-production review and any additional actions taken in the batch record (Annexure-1) and deviation report (Annexure-2).

5.5 Calibration and Maintenance of PAT Tools

  1. Perform regular calibration of the PAT tools to ensure accurate and reliable data. Calibration should be done according to the manufacturer’s instructions or as specified in the preventive maintenance schedule.
  2. Inspect sensors, probes, and other monitoring components for wear and tear. Replace any damaged components before the next production run.
  3. Verify that all PAT tools are functioning properly before starting each production batch. Any malfunctioning equipment should be addressed by the maintenance team before production begins.
  4. Maintain a log of calibration and maintenance activities in the maintenance log (Annexure-3), ensuring that all actions are documented for traceability.

5.6 Documentation and Record-Keeping

  1. Ensure that all real-time monitoring data, including any deviations and corrective actions, is documented in the batch record (Annexure-1).
  2. Store all PAT data and related records in the appropriate electronic systems, ensuring compliance with regulatory data integrity requirements.
  3. Maintain records of any deviations or process changes in the deviation report (Annexure-2), and ensure that these records are available for review during audits or inspections.
  4. Ensure that all records are signed, dated, and stored in accordance with the company’s record retention policy.

5.7 Troubleshooting PAT Tool Issues

  1. If the PAT system malfunctions or the data is inconsistent, immediately stop the production run and diagnose the issue.
  2. Check the system connections, calibration settings, and sensor functionality. Replace or recalibrate any faulty components as needed.
  3. Document the troubleshooting process and any corrective actions taken in the maintenance log (Annexure-3) and batch record (Annexure-1).
  4. Notify the QA department if any deviations from the specified process are detected that cannot be resolved immediately.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PAT: Process Analytical Technology
  • API: Active Pharmaceutical Ingredient

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)
  3. Maintenance Log (Annexure-3)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
  • ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Record

Batch Number PAT Parameters Tablet Weight Tablet Hardness Comments
Batch 001 Tablet Weight: 500 mg, Hardness: 7 kg 500 mg 7 kg No deviations

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/09/2025 Batch 003 Tablet weight variance Adjusted feed rate John Doe

Annexure-3: Maintenance Log

Maintenance Date Equipment Component Maintenance Performed Performed By Comments
15/09/2025 PAT System Calibration, System Check Jane Smith System verified, all parameters within range

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 PAT Integration Enhanced Monitoring Efficiency QA Head
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