Standard Operating Procedure for Handling Soft Gelatin Capsule Leaks

Department	Capsule Manufacturing
SOP No.	SOP/CM/094/2025
Supersedes	SOP/CM/094/2022
Page No.	Page 1 of 5
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to establish a standardized procedure for handling soft gelatin capsule leaks. Soft gelatin capsules may sometimes develop leaks due to issues such as improper sealing, material defects, or mechanical damage. This procedure ensures that leaked capsules are identified, isolated, and handled appropriately to maintain product quality and prevent contamination.

2. Scope

This SOP applies to the handling of soft gelatin capsules that have been identified as having leaks during or after the production process. It covers the detection, isolation, and corrective actions for leaks to ensure compliance with quality standards.

3. Responsibilities

• Production Operators: Responsible for identifying, isolating, and reporting any soft gelatin capsules with leaks during the production process.
• Quality Control (QC) Team: Responsible for performing detailed inspections, testing, and verifying the integrity of capsules suspected to have leaks. Ensures that all leaking capsules are properly documented and handled.
• Quality Assurance (QA) Team: Ensures that the SOP is followed, investigates the root causes of leaks, and ensures that corrective actions are implemented.
• Production Supervisor: Oversees the process of identifying and managing leaking capsules and ensures adherence to the SOP throughout the manufacturing process.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that any leaking soft gelatin capsules are identified, isolated, and handled according to this SOP. The QA Manager is responsible for reviewing and approving the corrective actions taken in response to leaks.

5. Procedure

5.1 Detection of Leaking Soft Gelatin Capsules

The detection of leaking soft gelatin capsules should be done as follows:

1. Visual Inspection
   1. During the production process, all soft gelatin capsules should undergo a visual inspection to check for any signs of leakage, such as the presence of liquid on the surface of the capsule or discoloration.
   2. Operators should also check for defects in the capsule shell that may indicate a potential leak, such as cracks, holes, or incomplete seals.
2. Use of Leak Detection Equipment
   1. In addition to visual inspection, consider using automated leak detection systems such as vacuum testers or pressure tests to identify capsules with leaks.
   2. The leak detection equipment should be calibrated regularly to ensure accurate results.

5.2 Isolating Leaking Capsules

If leaking capsules are identified, they must be immediately isolated and handled as follows:

1. Stop the Production Line
   1. If a significant number of leaking capsules are detected, stop the production line to prevent further contamination or mixing with intact capsules.
2. Remove Leaked Capsules from the Line
   1. Remove all capsules identified as leaking and place them in a designated quarantine area to prevent them from being packaged.
   2. Label the quarantine area as containing “Leaking Capsules” for clear identification.

5.3 Investigating the Cause of Leaks

Once the leaking capsules are isolated, an investigation into the root cause should be conducted:

1. Examine the Capsule Production Process
   1. Investigate the sealing process for any equipment malfunctions, such as inconsistent pressure or heat, which may have led to incomplete sealing of the capsules.
   2. Inspect the raw materials used for any defects, such as gelatin inconsistencies or poorly formulated excipients, which may have affected the capsule shell’s integrity.
2. Identify Equipment Issues
   1. Check the equipment used for capsule formation and sealing. Ensure that all equipment is calibrated correctly and maintained regularly.
   2. If an equipment malfunction is identified, it should be repaired or replaced as necessary.
3. Review Operator Practices
   1. Review the operator’s procedures to ensure that they are following the correct steps during the capsule filling and sealing process.
   2. If human error is identified, retraining may be necessary to prevent future leaks.

5.4 Corrective Actions for Leaks

Once the root cause of the leaks has been identified, corrective actions should be implemented:

1. Fix Equipment or Material Issues
   1. If equipment issues were identified, ensure that the necessary repairs are made to prevent further leaks. If material issues were identified, replace the defective materials.
2. Retrain Operators
   1. If human error was identified, retrain the operators on the correct procedures to ensure the proper handling and sealing of the capsules.
3. Revalidate the Production Process
   1. Once corrective actions have been implemented, revalidate the entire production process to ensure that the capsules meet all quality and safety standards.

5.5 Documenting the Handling of Leaking Capsules

Accurate documentation is crucial for tracking leaking capsules and ensuring compliance:

1. Document the Leak Incident
   1. Document all incidents involving leaking capsules, including the batch number, the number of capsules affected, the cause of the leak, and the corrective actions taken in the Deviation Log (Annexure-1).
2. Update Batch Records
   1. Ensure that the Batch Production Record (BPR) reflects any deviations or issues related to leaking capsules, including actions taken to address the problem.

5.6 Disposition of Leaked Capsules

Leaked capsules should be appropriately disposed of as follows:

1. Segregate Leaked Capsules
   1. Leaked capsules should be segregated in a designated area, clearly marked as “Leaked Capsules” to prevent accidental packaging.
2. Dispose of Leaked Capsules
   1. Once the cause of the leaks has been resolved and no further leaks are detected, dispose of the leaking capsules following company policies for waste management and in compliance with regulatory requirements.

6. Abbreviations

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

7. Documents

1. Deviation Log (Annexure-1)
2. Batch Production Record (BPR) (Annexure-2)
3. Leaked Capsule Disposal Log (Annexure-3)

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: Deviation Log

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Deviation ID	Description	Corrective Action Taken	Operator Name	Approval Status
DEV-001	Leaking capsule identified during inspection	Isolated and segregated capsules, rechecked sealing equipment	Jane Smith	Approved

Annexure-2: Batch Production Record (BPR)

Batch ID	Raw Material Used	Quantity Used	Capsules Produced	Leaked Capsules	Corrective Action
Batch 001	API	500 kg	100,000 capsules	50 leaked capsules	Equipment recalibration

Annexure-3: Leaked Capsule Disposal Log

Batch ID	Leaked Capsules Quantity	Disposal Date	Operator Name	Disposal Method
Batch 001	50 capsules	02/02/2025	John Doe	Incineration

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 handling procedure and documentation	Standardization	QA Head