Standard Operating Procedure for Monitoring Capsule Shape Uniformity

Department	Capsule Manufacturing
SOP No.	SOP/CM/095/2025
Supersedes	SOP/CM/095/2022
Page No.	Page 1 of 6
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 monitoring the shape uniformity of capsules during manufacturing. Ensuring that the capsules maintain consistent shape is crucial for product quality, performance, and compliance with regulatory standards.

2. Scope

This SOP applies to all capsule manufacturing processes that involve the shaping of capsules, including hard and soft gelatin capsules. It covers the steps for inspecting, measuring, and documenting capsule shape uniformity during the production process.

3. Responsibilities

• Production Operators: Responsible for performing initial inspections of capsule shape and reporting any irregularities in shape or appearance.
• Quality Control (QC) Team: Responsible for conducting detailed inspections and measurements of capsule shape to ensure uniformity and compliance with specifications.
• Quality Assurance (QA) Team: Ensures that the SOP is followed, investigates deviations in capsule shape, and implements corrective actions as needed.
• Production Supervisor: Oversees the monitoring process, ensures compliance with the SOP, and takes corrective actions if required.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that capsule shape uniformity is consistently monitored and maintained throughout the production process. The QA Manager is responsible for overseeing the process and ensuring compliance with regulatory requirements.

5. Procedure

5.1 Capsule Shape Monitoring

During production, the shape of capsules should be monitored as follows:

1. Initial Inspection
   1. At regular intervals, production operators should visually inspect the capsules for obvious shape defects, such as irregularities in size, cracks, or deformations.
   2. If any irregularities are detected, the affected capsules should be isolated and removed from the production line for further inspection.
2. Use of Automated Equipment for Shape Monitoring
   1. Where applicable, automated systems such as capsule sorting machines or vision inspection systems should be used to detect irregular capsule shapes.
   2. The equipment should be calibrated and maintained regularly to ensure accuracy and consistency in detecting shape defects.
3. Shape Uniformity Specifications
   1. The capsules should meet the pre-determined specifications for shape uniformity. These specifications should include acceptable limits for size, roundness, and symmetry of the capsules.
   2. Capsules that deviate from these specifications should be segregated for further analysis or disposal if necessary.

5.2 Measuring Capsule Shape Uniformity

For accurate assessment of capsule shape uniformity, follow these steps:

1. Sampling
   1. At regular intervals, select random samples of capsules from the production line for detailed measurements of shape uniformity.
   2. The sample size should be statistically valid, typically 10-20 capsules per batch, depending on the production scale.
2. Measurement of Shape
   1. Use calibrated equipment, such as calipers or automated vision systems, to measure the dimensions of the capsules, including length, diameter, and any other relevant features.
   2. Ensure that the capsules are measured in multiple positions (e.g., across the capsule length and width) to detect any shape variation.
3. Record the Results
   1. Document the measurements and compare them with the established shape specifications.
   2. Any capsules that fall outside the acceptable limits should be flagged, and further investigation should be conducted.

5.3 Handling Capsules with Shape Irregularities

If capsules with shape irregularities are found, take the following actions:

1. Segregate Affected Capsules
   1. Any capsules with shape irregularities should be immediately segregated from the production line to prevent them from being packaged.
   2. Place the affected capsules in a designated area for further investigation or disposal.
2. Investigate the Cause of Irregularities
   1. Investigate the root cause of the shape irregularities, which may include issues with the capsule machine settings, raw material quality, or environmental conditions.
   2. Check if the capsule formation equipment is properly calibrated and functioning as expected.
3. Take Corrective Actions
   1. If the issue is identified as equipment-related, adjust the settings or perform maintenance on the machine to restore proper capsule shape.
   2. If raw material defects are found, investigate the material supplier and take corrective actions, including material replacement or additional testing.

5.4 Documenting Capsule Shape Monitoring

Accurate documentation is essential for maintaining traceability and ensuring compliance:

1. Maintain Monitoring Records
   1. Document all inspections, measurements, and any irregularities found during the monitoring process in the Capsule Shape Monitoring Log (Annexure-1).
   2. Ensure that the logs include relevant details such as batch number, production date, capsule measurements, and any corrective actions taken.
2. Reporting Irregularities
   1. If any deviations from shape uniformity are found, report them immediately to the QA team and document the deviation in the Deviation Log (Annexure-2).

5.5 Final Approval and Packaging

Once capsule shape uniformity has been confirmed, the following steps should be taken:

1. QA Review and Approval
   1. The QA team should review the shape monitoring records and any corrective actions taken before approving the batch for packaging.
   2. If the capsules meet the required shape uniformity standards, the batch can proceed to the packaging stage.
2. Final Approval for Packaging
   1. Once the QA team approves the shape uniformity, the production batch can be signed off for packaging and labeling.

6. Abbreviations

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

7. Documents

1. Capsule Shape Monitoring Log (Annexure-1)
2. Deviation Log (Annexure-2)
3. Batch Production Record (BPR) (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: Capsule Shape Monitoring Log

Batch ID	Capsule Shape Measurements	Deviation Found	Corrective Action	Operator Name
Batch 001	Length: 19mm, Width: 8mm	No	None	John Doe

Annexure-2: Deviation Log

Deviation ID	Description	Corrective Action Taken	Operator Name	Approval Status
DEV-001	Capsules with You said: Continue ChatGPT said: html Copy	Capsules with irregular shape detected	Recalibrated capsule machine settings	Jane Smith	Approved

Annexure-3: Batch Production Record (BPR)

Batch ID	Production Date	Capsules Produced	Shape Inspection Result	Deviation Recorded	Corrective Action
Batch 001	01/02/2025	100,000 capsules	Pass	No deviation	None

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 capsule shape measurement process and corrective actions	Standardization	QA Head