with this SOP and reviews the adjustment records to verify that all adjustments align with regulatory and GMP standards.

Maintenance Team: Responsible for ensuring that the capsule filling machine is properly maintained and calibrated, including the adjustment of machine parameters when required.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule filling machine parameters are adjusted and maintained according to this SOP. The QA Manager is responsible for reviewing records and ensuring compliance with regulatory requirements.

5. Procedure

5.1 Pre-Adjustment Preparation

Before adjusting the machine parameters, ensure the following steps are completed:

1. Equipment Inspection
   1. Ensure the capsule filling machine is clean and free from any previous batch residues. Inspect all parts of the machine, including the hopper, dosing system, and capsule alignment mechanisms, for signs of wear or damage.
   2. Verify that the filling machine is properly calibrated and operating within the specified parameters set by the manufacturer.
2. Material Preparation
   1. Ensure that the capsule fill material is prepared according to the product specifications, including the correct viscosity, particle size, and moisture content.
   2. Check that the capsules (shells) are of the correct size and in proper condition for filling.
3. Documentation
   1. Record the initial machine settings, including the capsule size, fill weight, and other key parameters, in the batch production record.

5.2 Adjusting Capsule Filling Machine Parameters

Once pre-adjustment preparation is completed, follow these steps to adjust the machine parameters:

1. Set Fill Weight
   1. Adjust the fill weight by changing the volume of material dispensed into each capsule. This is done by adjusting the dosing system on the machine.
   2. Ensure that the fill weight is set according to the target specification. Perform a weight check on a sample of capsules to verify that the fill weight is within the acceptable range (±5% of the target weight).
2. Adjust Capsule Alignment
   1. Ensure that the capsules are aligned correctly within the filling machine. Misalignment can cause issues with capsule filling and closure. Adjust the alignment mechanisms as needed to ensure that the capsules are properly seated in the filling and closing areas of the machine.
3. Set Capsule Closure
   1. Adjust the sealing system to ensure that the capsules are properly closed after filling. The closure should be tight and uniform to prevent leakage of the fill material.
   2. Verify that the closure is secure by inspecting a sample of capsules for any signs of improper sealing, such as broken or poorly closed capsules.
4. Adjust Machine Speed
   1. Adjust the machine speed based on the production requirements. Ensure that the speed is set to allow for optimal capsule filling without compromising the accuracy of the fill weight or closure.

5.3 Verifying Adjustments

After making adjustments to the capsule filling machine parameters, follow these steps to verify that the changes are correct:

1. Perform Weight Checks
   1. Weigh a sample of filled capsules to ensure that the fill weight is within the acceptable range. This check should be done regularly throughout the production run to confirm that the adjustments have achieved the desired results.
2. Visual Inspection
   1. Perform a visual inspection of the capsules to ensure that they are properly aligned and that the closures are secure. Reject any capsules that show signs of misalignment or poor sealing.
3. Functional Test
   1. Test the filling and sealing functions of the machine by running a small test batch of capsules. Inspect the test batch to ensure that the capsules meet the required specifications for fill weight, size, and closure.

5.4 Post-Adjustment Documentation

After adjusting the machine parameters and verifying their accuracy, ensure the following documentation is completed:

1. Machine Setting Records
   1. Record the final machine settings, including the fill weight, capsule alignment, closure settings, and machine speed in the batch production record.
2. Quality Control Records
   1. Document the results of the weight checks, visual inspections, and functional tests. Include any deviations from the target specifications and the corrective actions taken to resolve them.
3. Deviation Reports
   1. Document any deviations from the required machine parameters and the corrective actions implemented to address the issue.

5.5 Maintenance and Calibration

Ensure that the machine remains in good working condition to maintain the accuracy of the filling and sealing process:

1. Routine Maintenance
   1. Perform routine maintenance on the capsule filling machine, including cleaning, lubrication, and inspection of key components such as the dosing system, capsule feeder, and sealing mechanism.
2. Calibration
   1. Ensure that the machine is calibrated at regular intervals as per the manufacturer’s guidelines. Verify that the fill weight, capsule alignment, and sealing parameters are within the specified limits.

5.6 Documentation and Record-Keeping

Maintain accurate records of all adjustments made to the capsule filling machine:

1. Adjustment Logs
   1. Document all adjustments made to the machine, including the date, the operator performing the adjustment, and the reason for the change. Include the final machine settings and any observations made during the process.
2. Deviation and Corrective Action Records
   1. Maintain records of any deviations from the target settings, the corrective actions taken, and the final outcome after the corrections are implemented.

6. Abbreviations

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

7. Documents

1. Machine Adjustment Log (Annexure-1)
2. Quality Control Test Record (Annexure-2)
3. Deviation and Corrective Action Record (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: Machine Adjustment Log

Batch ID	Machine ID	Parameter Adjusted	Operator	Date
Batch 001	Filling Machine 10	Fill Weight	John Doe	01/02/2025

Annexure-2: Quality Control Test Record

Test Type	Result	Specification	Remarks
Capsule Weight	Pass	±5% of target weight	Meets standards

Annexure-3: Deviation and Corrective Action Record

Deviation ID	Description	Corrective Action	Action Taken By
DR-001	Overfilled Capsules	Adjusted fill material flow rate	Manufacturing Supervisor

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 adjustment parameters	Standardization	QA Head