for online process monitoring and control.

3. Responsibilities

• Production Chemist: Operate PAT equipment, record real-time data, and escalate deviations.
• Process Development Scientist: Configure, calibrate, and validate PAT tools for specific processes.
• QA Officer: Review PAT-based monitoring records and ensure data integrity and compliance.
• Engineering Team: Ensure sensor and software systems are maintained, calibrated, and integrated.

4. Accountability

The Process Technology Manager is accountable for PAT deployment. The QA Head is responsible for procedural compliance and approval of monitoring records.

5. Procedure

5.1 Overview of PAT Tools

1. Common PAT tools in use include:
   • NIR Spectroscopy: For blend uniformity and moisture content.
   • Raman Spectroscopy: For reaction monitoring and identity confirmation.
   • UV-Vis: For analyte concentration during synthesis.
   • FTIR/IR: For real-time process endpoint detection.

5.2 Pre-Operation Checks

1. Verify calibration status of the PAT tool and associated software.
2. Check sensor probe integrity, cleanliness, and connectivity.
3. Ensure interface with SCADA/DCS or standalone system is functional.
4. Confirm process batch parameters are loaded and approved by QA.

5.3 Installation and Monitoring

1. Install sensor probes in designated reactor ports or process lines as per validation protocol.
2. Start data acquisition using the validated software platform (e.g., SynTQ, SIEMENS SIMATIC).
3. Monitor real-time parameters and trends displayed on screen:
   • Peak shifts (in NIR or Raman)
   • Absorbance levels
   • Moisture signature
4. Document critical events or signals as per Annexure-1 (PAT Monitoring Logbook).

5.4 Alarm and Out-of-Trend Handling

1. In case of deviation or out-of-trend signals:
   • Pause process if required.
   • Notify shift in-charge and QA immediately.
   • Initiate deviation form referencing PAT log and batch number.
2. Ensure all excursions are documented and investigated.

5.5 Data Storage and Security

1. All PAT data shall be stored on secure servers with restricted access.
2. Backups shall be created daily and retained for a minimum of 5 years.
3. Audit trails must be enabled and reviewed periodically by QA.

5.6 Post-Operation Tasks

1. Remove and clean sensor probes using lint-free cloth and solvent as per SOP.
2. Switch off hardware and software systems after completion.
3. Record process summary and parameters in batch manufacturing record and Annexure-1.

6. Abbreviations

• SOP: Standard Operating Procedure
• PAT: Process Analytical Technology
• NIR: Near Infrared
• QA: Quality Assurance
• DCS: Distributed Control System
• SCADA: Supervisory Control and Data Acquisition

7. Documents

1. PAT Monitoring Logbook (Annexure-1)
2. PAT Equipment Calibration Log
3. Deviation Form

8. References

• ICH Q8 – Pharmaceutical Development
• ICH Q9 – Quality Risk Management
• US FDA Guidance on PAT Framework
• WHO TRS 1019 Annex 3 – PAT in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PAT Monitoring Logbook

Date	Batch No.	Tool Used	Stage	Parameters Monitored	Observed Value	Operator	Remarks
13/04/2025	API-20250413	NIR	Drying	Moisture Content	1.1%	Ravi Kumar	Complies

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New PAT Implementation	QA Head
13/04/2025	2.0	Expanded tools and added data integrity section	Audit Recommendation	QA Head