approves the PQ documentation to ensure compliance with GMP and regulatory standards.

Production Team: Ensures that the capsule printing machine is integrated into the production line and ready for regular use after successful PQ completion.

4. Accountability

The Engineering Supervisor is responsible for ensuring the proper setup and configuration of the capsule printing machine for PQ testing. The QA Manager is responsible for reviewing and approving the PQ documentation, ensuring the process meets GMP and regulatory standards. The Production Supervisor is responsible for ensuring the equipment is ready for production after successful PQ completion.

5. Procedure

5.1 Pre-Qualification Setup

Before starting the Performance Qualification process, ensure the following preparations are completed:

1. Review PQ Plan
   1. Review the PQ plan to ensure it includes all the necessary tests, operational parameters, and acceptance criteria. The plan should be approved by the QA department before initiating PQ.
2. Prepare the Installation Environment
   1. Ensure that the capsule printing machine is installed and operational. Verify that it is connected to the required utilities (electricity, compressed air, etc.).
   2. Ensure the machine is installed in a clean, well-lit, and accessible area, with proper environmental controls, such as temperature and humidity.
3. Calibrate and Verify Equipment
   1. Ensure that the capsule printing machine is calibrated according to the manufacturer’s specifications. Check the alignment of the printing system, sensors, and control mechanisms. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Performance Qualification Testing

Follow these steps to conduct the performance qualification of the capsule printing machine:

1. Verify Printing System Functionality
   1. Test the machine’s ability to print on capsules, ensuring that the print quality meets the specified standards, such as clarity, legibility, and adherence to product specifications.
   2. Ensure the system operates correctly for various capsule sizes and print types (e.g., logos, numbers, codes).
2. Check Print Speed and Accuracy
   1. Run tests to verify that the print speed and accuracy meet production requirements. Ensure the print density and positioning are consistent throughout the run.
3. Validate Capsule Handling
   1. Test the system’s ability to handle capsules correctly during the printing process, ensuring there is no damage to the capsules during printing.
   2. Check for proper alignment of capsules in the machine to ensure consistent printing results.
4. Verify Machine Performance with Production Run
   1. Conduct a short production run, simulating normal operating conditions, and record performance data such as printing speed, downtime, and print quality.
   2. Ensure that the machine maintains consistent performance and meets all specified acceptance criteria throughout the run.
5. Document PQ Results
   1. Document the results of all performance tests and verify that the capsule printing machine meets the specified acceptance criteria. Record results in the PQ Log (Annexure 2).
   2. If any deviations are observed, investigate the cause and take corrective actions. Re-test the machine until it meets all operational requirements.

5.3 Post-Qualification Activities

After successful completion of the PQ process, perform the following tasks:

1. Operator Training
   1. Provide training to operators on the proper use of the capsule printing machine, including operational controls, troubleshooting, and maintenance procedures.
2. Sign-Off and Approval
   1. Ensure that the PQ process is completed successfully, and the machine is signed off for use in production by the QA Manager. The PQ Report should be approved and filed for record-keeping.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• PQ: Performance Qualification
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment

7. Documents

1. Annexure 1: Equipment Calibration Log
2. Annexure 2: Performance Qualification Log
3. Annexure 3: Performance Qualification Report

8. References

• FDA Guidelines on Equipment Performance Qualification
• Good Manufacturing Practice (GMP) Guidelines
• USP <1058> – Equipment Qualification

9. SOP Version

Version: 2.0

10. Approval Section

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	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Printing Machine 405	01/02/2025	John Doe	Calibration of printing speed and ink application	01/02/2026

Annexure 2: Performance Qualification Log

Batch ID	PQ Date	Operator	Test Type	Results
Batch 001	02/02/2025	Jane Smith	Print Quality Test	Pass

Annexure 3: Performance Qualification Report

Batch ID	Test Date	Test Type	Results	Remarks
Batch 001	02/02/2025	Operational Test	Pass	Machine performed as expected, no issues detected

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for performance qualification of capsule printing machines	QA Head
01/02/2025	2.0	Updated testing parameters and added new machine functionality tests	Improvement of testing methods and expanded functionality tests	QA Head