SOP Guide for Pharma

Capsule: SOP for Operational Qualification (OQ) of Capsule Inspection Machines – V 2.0

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Capsule: SOP for Operational Qualification (OQ) of Capsule Inspection Machines – V 2.0

Standard Operating Procedure for Operational Qualification (OQ) of Capsule Inspection Machines

Department Capsule Manufacturing
SOP No. SOP/CM/167/2025
Supersedes SOP/CM/167/2022
Page No. Page 1 of 8
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to outline the Operational Qualification (OQ) process for capsule inspection machines. OQ ensures that the capsule inspection machine operates within specified limits and performs as expected during production. This SOP provides a structured approach to validating the operational functionality of the capsule inspection machine in compliance with GMP and regulatory standards.

2. Scope

This SOP applies to the operational qualification of capsule inspection machines used in the capsule manufacturing process. It covers all aspects of the OQ process, including machine setup, functional tests, and documentation required to ensure the machine meets operational requirements.

3. Responsibilities

4. Accountability

The Engineering Supervisor is responsible for ensuring that the capsule inspection machine is set up according to the design specifications and is ready for OQ testing. The QA Manager is responsible for reviewing and approving the OQ documentation and ensuring compliance with GMP and regulatory standards. The Production Supervisor ensures the equipment is ready for production after successful completion of the OQ process.

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5. Procedure

5.1 Pre-Operational Setup

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

  1. Review OQ Plan
    1. Review the OQ plan provided by the manufacturer or engineering team. Ensure the plan includes the functional tests, acceptance criteria, and operational parameters to be validated.
  2. Prepare Installation Environment
    1. Ensure the capsule inspection machine is installed and located in the appropriate area of the production line. Verify that the machine is connected to the required utilities (power, compressed air, etc.).
    2. Verify that the area meets the necessary conditions, including proper lighting and accessibility to operators for safe operation.
  3. Calibration and Equipment Checks
    1. Ensure that the capsule inspection machine is calibrated and functioning as per the design specifications. Record calibration details in the Equipment Calibration Log (Annexure 1).
    2. Ensure that any ancillary equipment, such as sensors, cameras, and control systems, are operational and calibrated.

5.2 Operational Qualification Process

Follow these steps to conduct the operational qualification of the capsule inspection machine:

  1. Verify Functional Components
    1. Test the basic functional components of the machine, including start/stop buttons, speed control, and emergency stop features. Ensure that all components are responsive and function within specified limits.
  2. Verify Operational Parameters
    1. Test the machine’s operational parameters, including speed, throughput, and accuracy of capsule inspection. Verify that the machine operates within the set limits specified in the OQ plan.
    2. Ensure that the machine’s capacity (number of capsules per minute) meets the production requirements.
  3. Perform Functional Tests
    1. Run functional tests, such as inspecting capsules for size, shape, color, and defects. Validate the machine’s ability to detect defective capsules and reject them properly.
    2. Perform tests using different capsule types (e.g., hard gelatin, soft gelatin) to verify that the machine functions as expected across various products.
  4. Verify Alarm and Safety Features
    1. Test the alarm systems to ensure that any faults, such as jammed capsules or machine errors, trigger the appropriate alarms and shutdown procedures.
    2. Verify that the machine’s safety features, including guards and emergency stops, are functioning correctly.
  5. Document OQ Results
    1. Document the results of all operational tests and verify that all parameters meet the acceptance criteria. Record the results in the OQ Log (Annexure 2).
    2. If any deviations or failures occur, document them in the OQ report 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 OQ process, ensure the following tasks are completed:

  1. Operator Training
    1. Train operators on how to use the capsule inspection machine, including basic operations, troubleshooting, and safety procedures.
  2. Sign-Off and Approval
    1. Ensure that the OQ process is completed successfully, and the machine is signed off by the QA Manager for use in production. The OQ 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: Operational Qualification Log
  3. Annexure 3: Operational Qualification Report

8. References

9. SOP Version

Version: 2.0

10. Approval Section

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
Inspection Machine 300 01/02/2025 John Doe Calibration of camera focus and capsule detection sensors 01/02/2026

Annexure 2: Operational Qualification Log

Batch ID OQ Date Operator Test Type Results
Batch 001 02/02/2025 Jane Smith Visual Inspection Test Pass

Annexure 3: Operational Qualification Report

Batch ID Test Date Test Type Results Remarks
Batch 001 02/02/2025 Functionality Test Pass Machine operates within expected parameters

12. Revision History

< You said: Continue ChatGPT said: Here is the continuation for SOP 167: SOP for Operational Qualification (OQ) of Capsule Inspection Machines, including the Revision History section: html Copy

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for operational qualification of capsule inspection machines QA Head
01/02/2025 2.0 Updated operational checks and added new acceptance criteria for machine functionality Improvement of operational qualification tests and incorporation of updated requirements QA Head
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