quality standards.

Quality Assurance (QA) Team: Ensures that metal detection processes comply with GMP guidelines and regulatory standards. Reviews metal detector logs and approves batches for release.

Maintenance Team: Responsible for regular maintenance, calibration, and troubleshooting of metal detectors to ensure optimal performance.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that metal detectors are set up, calibrated, and operated correctly according to this SOP. The QA Manager is responsible for reviewing and approving any deviations from the SOP and ensuring regulatory compliance.

5. Procedure

5.1 Setup and Calibration of Metal Detectors

Before starting production, ensure that the metal detector is correctly set up and calibrated:

1. Check Equipment Condition
   1. Inspect the metal detector for any signs of damage or malfunction. Ensure that all parts, such as belts, sensors, and detection coils, are in good condition.
   2. Ensure that the metal detector’s power supply and control systems are operational.
2. Calibrate the Metal Detector
   1. Perform calibration using known metal test pieces (typically ferrous, non-ferrous, and stainless steel) to ensure the detector is sensitive to the appropriate metal types.
   2. Set the sensitivity level based on the product and type of metal contamination that may be encountered. Calibration should be done in accordance with the equipment manufacturer’s instructions.
3. Set the Detection Parameters
   1. Set the detection parameters, including sensitivity and reject thresholds, based on the product and batch requirements. The sensitivity should be set to detect metallic contamination without causing false rejections.
4. Verify Calibration
   1. Run a test batch of capsules through the metal detector to verify that it detects metal pieces as expected. Record the test results and make adjustments if necessary.

5.2 Operating the Metal Detector During Production

Once the metal detector is set up, follow these steps to operate it during capsule manufacturing:

1. Feed Capsules through Metal Detector
   1. Ensure that capsules are fed properly into the metal detection system. They should be spaced evenly to avoid overlapping, which could interfere with the detection process.
   2. Monitor the flow of capsules to ensure that they are being processed at the correct speed and are properly positioned in the detection area.
2. Monitor Metal Detection Process
   1. Continuously monitor the metal detector during production to ensure it is operating at optimal levels. Look for any alerts or system errors that could indicate a malfunction or calibration issue.
   2. Check the detection logs for consistency and ensure that no deviations are occurring.
3. Respond to Alerts
   1. If the metal detector detects contamination, it will trigger an alert or reject the capsule. Respond immediately by halting the production line and investigating the cause of the contamination.
   2. Document the rejection, noting the type of metal detected, the number of affected capsules, and the corrective actions taken.

5.3 Handling Detected Contamination

If metallic contamination is detected, take the following steps to manage the situation:

1. Reject Contaminated Capsules
   1. Remove any affected capsules from the production line immediately. These capsules should be placed in a designated rejection bin labeled “Metal Contamination.” Ensure that contaminated capsules are not mixed with good capsules.
2. Investigate the Source of Contamination
   1. Investigate the root cause of the contamination. Check the equipment for any sources of metal contamination, such as faulty machine parts or broken components. Review the incoming raw materials to ensure they are free from contaminants.
   2. If the contamination is due to equipment malfunction, shut down the machine for maintenance and troubleshooting.
3. Corrective Actions
   1. Implement corrective actions, such as repairing the equipment, replacing damaged components, or reviewing production processes. Document all actions taken in the deviation log.
4. Run Test Batches
   1. Run test batches after corrective actions to ensure that the issue has been resolved and that the metal detector is functioning correctly.

5.4 Routine Maintenance and Calibration

Perform regular maintenance and calibration checks to ensure that the metal detector remains in good working order:

1. Daily Maintenance
   1. Perform a quick inspection of the metal detector before and after each production shift to ensure that there are no obvious signs of damage or malfunction.
   2. Clean the metal detector according to the manufacturer’s instructions to prevent buildup of dust or contaminants that could affect its sensitivity.
2. Monthly Calibration
   1. Perform a full calibration of the metal detector at least once a month using metal test pieces. Ensure that the detector is still sensitive enough to detect the appropriate size of metal particles.
3. Record Calibration Results
   1. Document all calibration results in the equipment maintenance log and review the records periodically to ensure consistency.

5.5 Documentation and Reporting

Ensure that all actions related to metal detection are thoroughly documented:

1. Document Detection Results
   1. Record the results of each metal detection check in the metal detector log, including any rejected capsules and corrective actions taken.
2. Report Deviations
   1. If deviations or metal contamination issues occur, document them in the deviation report, including the steps taken to address the problem and prevent recurrence.
3. Review Logs
   1. Regularly review the metal detection logs to identify any trends or recurring issues. Investigate any patterns of contamination and implement preventive measures.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control

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• QA: Quality Assurance
• BPR: Batch Production Record
• HACCP: Hazard Analysis and Critical Control Points

7. Documents

1. Batch Production Record (BPR) (Annexure-1)
2. Metal Detector Calibration Log (Annexure-2)
3. Deviation Report (Annexure-3)
4. Metal Detection Test Log (Annexure-4)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Manufacturing
• HACCP Guidelines for Food and 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: Batch Production Record (BPR)

Batch ID	Production Date	Metal Detected	Operator Name	Action Taken
Batch 001	01/02/2025	None	John Doe	Approved

Annexure-2: Metal Detector Calibration Log

Calibration Date	Metal Type	Test Piece Size	Operator Name	Calibration Result
01/02/2025	Ferrous	3mm	Jane Smith	Pass
01/02/2025	Non-Ferrous	3mm	Jane Smith	Pass

Annexure-3: Deviation Report

Deviation ID	Description	Corrective Action Taken	Operator Name	Approval Status
DEV-001	Contaminated Capsule Detected	Repaired faulty sealing component, recalibrated metal detector	John Doe	Approved

Annexure-4: Metal Detection Test Log

Test ID	Test Date	Metal Type Detected	Capsules Affected	Action Taken
TEST-001	01/02/2025	Ferrous	10 capsules	Rejected, machine reset

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated calibration procedure and log format	Standardization	QA Head