Team: Reviews and approves the OQ documentation to ensure compliance with GMP and regulatory standards.

Production Team: Ensures that the inspection machine is properly integrated into the production line and ready for use after successful OQ completion.

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.

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.

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

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

7. Documents

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

8. References

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

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

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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