defects.

Quality Assurance (QA) Team: Responsible for ensuring that all troubleshooting and corrective actions comply with GMP standards and documenting any deviations or corrective actions in the batch production record (BPR).

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the troubleshooting process is followed properly. The QA Manager is responsible for reviewing all corrective actions and ensuring compliance with quality standards.

5. Procedure

5.1 Initial Assessment

The first step in troubleshooting capsule filling machine issues is to assess the situation to identify the problem:

1. Machine Stoppage
   1. If the capsule filling machine has stopped, check the control panel for any error messages or alarms that might indicate the cause of the stoppage. Record the error code, if available.
   2. Verify that all safety interlocks are engaged properly. Check the power supply, emergency stop buttons, and machine settings to ensure they are correct.
2. Unfilled or Misfilled Capsules
   1. If the machine is producing unfilled or misfilled capsules, check the following:
      • The correct formulation is loaded into the machine.
      • The dosing system is calibrated and functioning properly.
      • The capsule shells are properly aligned in the machine.
3. Capsule Shell Cracking or Damaging
   1. If the capsule shells are cracking or damaged, inspect the filling needles, the capsule shell feed system, and the sealing equipment for any issues.
   2. Ensure that the capsules are not exposed to excessive pressure or temperature during the filling process.

5.2 Troubleshooting Steps

If the initial assessment identifies the issue but does not provide a solution, follow these steps to troubleshoot the capsule filling machine:

1. Inspect and Adjust Filling System
   1. For issues with unfilled or misfilled capsules, check the filling station for any blockage, jamming, or mechanical malfunction. Adjust the fill volume and ensure that the fill material is flowing smoothly through the system.
   2. Calibrate the dosing system if necessary, and verify the settings are accurate for the formulation being used.
2. Examine the Capsule Feed Mechanism
   1. Check the capsule feed mechanism for any misalignment or obstruction that could be preventing capsules from entering the filling machine correctly.
   2. Clean the capsule feed and ensure that the capsules are moving smoothly through the system without any jams or blockages.
3. Inspect the Sealing and Closing System
   1. If capsules are not sealing properly, check the sealing system for any misalignment or worn-out parts. Adjust the sealing pressure and temperature settings to ensure a tight seal.
   2. Replace any worn or damaged sealing components, such as rubber or silicone seals, to prevent leakage or incomplete sealing.
4. Check for Air Leaks
   1. If air leaks are suspected, inspect the pneumatic system and seals for any visible cracks or wear. Ensure that all air pressure settings are correct and that no air leaks are affecting the operation of the machine.

5.3 Corrective Actions

Once the cause of the issue has been identified, the following corrective actions should be taken:

1. Recalibrate Equipment
   1. Recalibrate the dosing system, filling needles, and capsule feed system to ensure they are functioning correctly. Ensure that the capsule filling machine is set to the correct parameters for the specific batch being produced.
2. Replace Worn or Damaged Parts
   1. If any parts of the capsule filling machine are worn or damaged, such as filling needles, seals, or valves, replace them with new, compatible components to restore the machine’s functionality.
3. Test and Verify Repairs
   1. After the corrective actions are taken, run the machine with a small batch or sample to verify that the issue has been resolved. Monitor the machine closely during the test run to ensure the capsules are filled and sealed correctly.

5.4 Post-Troubleshooting Actions

After resolving the issue, the following steps should be followed:

1. Record the Issue and Corrective Actions
   1. Document the troubleshooting process in the batch production record (BPR), including a detailed description of the issue, the corrective actions taken, and any machine settings adjusted. This provides traceability for future reference and ensures compliance with regulatory requirements.
2. Review and Approve Corrective Actions
   1. The QA team should review and approve the corrective actions taken to ensure that the issue was resolved in compliance with GMP and quality standards. Any deviations from the standard process should be documented and reviewed accordingly.
3. Monitor Future Batches
   1. Monitor subsequent batches closely to ensure that the issue does not recur. If the problem persists, escalate the issue to senior engineering staff for further investigation and resolution.

5.5 Preventive Maintenance

To prevent future issues with the capsule filling machine, perform the following preventive maintenance actions:

1. Regular Equipment Calibration
   1. Calibrate the capsule filling machine regularly as per the manufacturer’s recommendations to ensure accurate filling and sealing during production.
2. Routine Inspection
   1. Perform routine inspections of the machine, including checking all moving parts, pneumatic systems, and sealing components for signs of wear and tear. Replace worn components as needed before they cause machine malfunctions.
3. Cleaning and Lubrication
   1. Clean the capsule filling machine thoroughly after each production run to remove any residue that may interfere with the filling process. Lubricate moving parts regularly to ensure smooth operation and minimize the risk of mechanical failure.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• BPR: Batch Production Record

7. Documents

1. Batch Production Record (BPR) (Annexure-1)
2. Deviation Report (Annexure-2)
3. Maintenance Log (Annexure-3)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• International Conference on Harmonization (ICH) Guidelines for 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	Issue Description	Corrective Actions Taken	Operator Name
Batch 001	Unfilled capsules	Recalibrated the dosing system	John Doe

Annexure-2: Deviation Report

Deviation ID	Description	Corrective Action Taken	Operator Name
DEV-001	Machine stopped unexpectedly	Checked error code, restarted machine	John Doe

Annexure-3: Maintenance Log

Equipment ID	Maintenance Date	Tasks Performed	Technician Name
Filling Machine 1	01/02/2025	Calibrated machine and checked seals	Jane Smith

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 troubleshooting steps	Standardization	QA Head