SOP Guide for Pharma

Capsule: SOP for Performance Qualification (PQ) of Capsule Printing Machines – V 2.0

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Capsule: SOP for Performance Qualification (PQ) of Capsule Printing Machines – V 2.0

Standard Operating Procedure for Performance Qualification (PQ) of Capsule Printing Machines

Department Capsule Manufacturing
SOP No. SOP/CM/168/2025
Supersedes SOP/CM/168/2022
Page No. Page 1 of 9
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to define the Performance Qualification (PQ) process for capsule printing machines. PQ is designed to ensure that the capsule printing machine operates according to the required specifications during actual production conditions. This SOP ensures that the capsule printing machine performs effectively, producing quality products in compliance with GMP and regulatory standards.

2. Scope

This SOP applies to the performance qualification of capsule printing machines used in the manufacturing process of capsules. It covers the operational testing, documentation, and criteria necessary to verify that the capsule printing machine functions within defined performance parameters.

3. Responsibilities

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.

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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.
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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

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7. Documents

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

8. References

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
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