with established specifications.

Quality Assurance (QA) Team: Ensures that the overall process complies with GMP standards and reviews any corrective actions taken to address variability.

Production Supervisor: Oversees the process and ensures that all team members are following the SOP. Takes necessary actions in the event of recurring variability issues.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all operators follow this SOP for monitoring and controlling capsule variability. The Maintenance Manager is responsible for ensuring that the equipment is functioning correctly. The QA Manager ensures that all deviations are addressed according to company policies and regulatory standards.

5. Procedure

5.1 Identifying Capsule Variability

Capsule variability is identified through regular inspections during production. The following steps must be followed:

1. Monitor Capsule Weight
   1. Weigh random samples of capsules at regular intervals during production. Ensure that the capsules meet the weight specifications.
   2. If the weight of the sample is outside the acceptable range, investigate the possible cause and take corrective action.
2. Monitor Capsule Fill Volume
   1. Inspect the fill volume of randomly selected capsules. Use appropriate equipment (e.g., automated volume measurement tools) to ensure consistency in fill volume.
   2. Adjust the filling system if the fill volume deviates from the target specification.
3. Monitor Capsule Sealing
   1. Inspect capsule sealing quality by visually checking for cracks, leaks, or incomplete seals.
   2. If sealing variability is observed, check the machine for malfunctions such as pressure inconsistencies or improper sealing temperature.

5.2 Correcting Capsule Variability

If variability is detected, take the following corrective actions:

1. Adjust Machine Settings
   1. If capsule weight or fill volume is inconsistent, adjust the machine settings such as filling volume, powder flow rate, or capsule alignment.
   2. For sealing issues, check the machine’s temperature and pressure settings, and make adjustments to achieve consistent sealing quality.
2. Check and Replace Consumables
   1. Inspect the capsule filling material, such as powders or liquids, for consistency. If inconsistencies are found, replace or recondition the material before continuing production.
   2. Inspect sealing equipment, including sealing bands and gaskets, for wear. Replace any worn-out components to restore proper function.
3. Perform Equipment Maintenance
   1. If variability persists despite adjustments, schedule a maintenance check. Inspect critical components, including the filler, seals, and capsule transport system, for malfunction or wear.
   2. Perform cleaning and calibration of the equipment if necessary.

5.3 Monitoring and Documentation

Once corrective actions are taken, it is important to document and monitor the effectiveness of the changes:

1. Record Variability Data
   1. Record the details of the variability event, corrective actions taken, and the results of the follow-up tests in the Variability Log (Annexure-1).
2. Re-sample and Re-test
   1. After making corrections, re-sample and re-test the capsules to ensure that the variability has been addressed. Continue monitoring at regular intervals to ensure consistency in product quality.

5.4 Resuming Production

After ensuring that capsule variability has been corrected, production can resume:

1. QA Review
   1. Have the QA team review all records, including machine settings, testing results, and corrective actions. Verify that the final product meets the required specifications.
2. Production Resumption
   1. If everything meets the required standards, resume capsule production and continue to monitor the machine’s performance closely during the next few production runs.

6. Abbreviations

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

7. Documents

1. Variability Log (Annexure-1)
2. Capsule Weight and Fill Volume Log (Annexure-2)
3. Deviation Log (Annexure-3)
4. Maintenance Log (Annexure-4)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Variability Log

Event ID	Batch ID	Type of Variability	Corrective Action	Operator	Approval Status
VAR-001	Batch 001	Weight Inconsistency	Adjusted fill volume	John Doe	Approved

Annexure-2: Capsule Weight and Fill Volume Log

Sample ID	Capsule Weight (mg)	Fill Volume (mL)	Pass/Fail	Operator
Sample 001	500	1.2	Pass	Jane Smith

Annexure-3: Deviation Log

Deviation ID	Batch ID	Description	Corrective Action	Operator	Approval Status
DEV-001	Batch 001	Irregular capsule weight	Recalibrated the machine	John Doe	Approved

Annexure-4: Maintenance Log

Equipment ID	Maintenance Date	Maintenance Activity	Performed By	Next Maintenance Due
Filling Machine 001	02/02/2025	Recalibrated filling system	Jane Smith	02/02/2026

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 and corrective actions	Improved accuracy and reduced errors	QA Head