company standards. Reviews records and approves corrective actions.

Production Supervisor: Oversees the identification and handling of deformed capsules, ensures that proper procedures are followed, and implements corrective actions to prevent recurrence.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that this SOP is followed and that deformed capsules are properly segregated and documented. The QA Manager is responsible for reviewing the batch records and ensuring compliance with regulatory standards.

5. Procedure

5.1 Identifying Deformed Capsules

Deformed capsules must be identified during various stages of production. The following steps outline the identification process:

1. Visual Inspection
   1. During the encapsulation process, visually inspect capsules for deformation, such as cracks, dents, or irregular shapes.
   2. Inspect the capsules on the conveyor belt, after drying, and during manual inspection for any visible signs of deformation.
2. Automated Inspection
   1. If an automated capsule inspection system is available, use it to detect deformed capsules based on predefined criteria, such as capsule size, shape, and weight.
3. Capsule Weight Check
   1. Weigh a sample of capsules to ensure uniformity. Deformed capsules may have irregular weight, which can be used as an indicator of defects.

5.2 Segregation of Deformed Capsules

Once deformed capsules are identified, they must be segregated from the rest of the production batch:

1. Manual Segregation
   1. Manually remove deformed capsules from the production line. Place them in designated containers labeled as “Rejected Capsules.” Ensure that the segregated capsules are not mixed with good capsules.
2. Automated Sorting
   1. If using automated sorting equipment, ensure that defective capsules are automatically removed from the line and placed in a separate bin for rejection.
3. Document the Rejection
   1. Document the number of deformed capsules rejected in the batch production record (BPR) and include a description of the issue, the number of affected capsules, and any corrective actions taken.

5.3 Investigation of Deformed Capsules

If a significant number of deformed capsules are identified, an investigation should be conducted to determine the root cause of the issue:

1. Identify Potential Causes
   1. Investigate potential causes of capsule deformation, including machine malfunctions, improper machine settings, or environmental factors such as temperature and humidity.
   2. Review the capsule formulation for any changes or inconsistencies that may affect the capsule material’s integrity.
2. Review Equipment Settings
   1. Check the capsule filling, drying, and sealing machines for any malfunction or improper settings that could lead to capsule deformation, such as excessive pressure, temperature fluctuations, or improper feed speeds.
3. Perform Root Cause Analysis
   1. Conduct a root cause analysis to identify any operational, mechanical, or formulation issues that need to be corrected to prevent future occurrences of capsule deformation.

5.4 Corrective and Preventive Actions

After identifying the root cause of the deformation, implement corrective and preventive actions:

1. Corrective Actions
   1. Adjust machine settings, repair or replace defective parts, and ensure that capsule feed systems and sealing equipment are operating within the correct parameters.
   2. If the deformation is related to the formulation, adjust the formulation or production process to ensure better capsule integrity.
2. Preventive Actions
   1. Introduce regular maintenance checks on machines to identify any potential issues before they cause deformation.
   2. Establish a more frequent inspection schedule for the capsules during production, particularly after major process steps, to identify defects early in the process.
3. Monitoring Effectiveness
   1. Monitor the production line for any recurrence of capsule deformation after corrective actions have been implemented. Record the results of this monitoring and adjust processes as needed.

5.5 Documentation and Reporting

All actions related to deformed capsules must be documented for traceability and regulatory compliance:

1. Document the Findings
   1. Document all findings related to deformed capsules, including the number of defective capsules, the investigation process, and any corrective actions taken in the batch production record (BPR) and deviation log.
2. Generate Deviation Report
   1. Generate a deviation report for any significant issues with capsule deformation, including root cause analysis, corrective actions, and preventive measures.

5.6 Reprocessing or Disposing of Deformed Capsules

If deformed capsules cannot be reworked or corrected, they must be properly disposed of:

1. Reprocessing Options
   1. If possible, rework the deformed capsules by reprocessing them through the machine. For example, capsules that are improperly filled but not damaged may be reprocessed with adjusted parameters.
2. Disposal of Defective Capsules
   1. If reprocessing is not possible, dispose of the deformed capsules according to company guidelines for waste management and environmental protection.

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. Capsule Inspection 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	Production Date	Deformed Capsules	Corrective Actions Taken	Operator Name
Batch 001	01/02/2025	20 deformed capsules	Adjusted sealing parameters	John Doe

Annexure-2: Deviation Report

Deviation ID	Description	Corrective Action Taken	Operator Name
DEV-001	Deformed capsules due to high sealing pressure	Reduced sealing pressure	John Doe

Annexure-3: Capsule Inspection Log

Sample ID	Defect Type	Action Taken	Inspector Name
Sample 001	Cracked Capsules	Segregated and disposed	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 procedures for handling deformed capsules	Standardization	QA Head