Standard Operating Procedure for Ensuring Uniformity of Capsule Weight During Production

Department	Capsule Manufacturing
SOP No.	SOP/CM/062/2025
Supersedes	SOP/CM/062/2022
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 outline the process for ensuring uniformity of capsule weight during production. This is essential to meet regulatory standards, improve product quality, and maintain consistency across capsules in terms of both weight and active ingredient content.

2. Scope

This SOP applies to all capsule manufacturing processes, where the weight of the capsules is a critical quality attribute. It covers the methods for weight monitoring, sampling frequency, and corrective actions to ensure uniformity of capsule weight throughout production.

3. Responsibilities

• Manufacturing Team: Responsible for operating the capsule filling equipment and ensuring that the correct amount of material is dispensed into each capsule. They must also ensure the weight of the capsules meets the required specifications.
• Quality Control (QC) Team: Responsible for performing regular weight checks during the production process and ensuring that capsules meet the required weight specifications. QC will also investigate any deviations.
• Quality Assurance (QA) Team: Ensures that this SOP is followed and that all necessary records are maintained for traceability. QA also reviews any deviations and approves corrective actions.
• Maintenance Team: Responsible for ensuring that all equipment used in the filling process is calibrated and maintained properly to avoid issues related to inconsistent capsule weight.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring uniformity of capsule weight during production and for overseeing the proper implementation of this SOP. The QA Manager is responsible for reviewing the records and ensuring compliance with regulatory requirements.

5. Procedure

5.1 Pre-Production Setup

Before beginning the production process, ensure the following steps are completed:

1. Equipment Inspection
   1. Inspect the capsule filling machine for cleanliness and ensure it is calibrated properly. Ensure that all components of the machine are functioning correctly, including the filling system, dosing system, and weight monitoring system.
2. Material Preparation
   1. Ensure that the fill material is prepared and meets the required specifications (e.g., consistency, viscosity, and moisture content). Ensure the material is homogeneous before it is fed into the filling machine.
3. Documentation
   1. Document the batch information, including capsule size, fill material, and the expected fill weight. Ensure that this documentation is ready before starting the production run.

5.2 Weight Monitoring During Production

During the production process, the following steps should be taken to monitor and ensure capsule weight uniformity:

1. Sample Collection
   1. Collect capsule samples at regular intervals during production to monitor weight uniformity. The sample size should be determined based on the batch size and statistical sampling principles.
2. Weight Measurement
   1. Weigh each sample capsule using a calibrated analytical balance. Record the weight of each capsule and compare it with the target weight specified for the batch.
3. Acceptance Criteria
   1. The weight of each capsule must be within ±5% of the target weight. If the capsules fall outside this range, further investigation is needed.
4. Automated Weight Monitoring
   1. If an automated weight monitoring system is used, ensure it is continuously monitoring the capsule weight during production. Any deviation from the target weight should trigger an alert and initiate corrective actions.

5.3 Corrective Actions for Weight Deviations

If weight deviations are detected, follow these steps:

1. Investigate the Cause
   1. Investigate the cause of the weight deviation. Potential causes may include incorrect machine settings, material variations, or improper machine calibration.
2. Corrective Action
   1. Based on the investigation, implement the necessary corrective actions, such as adjusting the fill material flow rate, recalibrating the machine, or replacing any malfunctioning components.
3. Rework or Discard Capsules
   1. If a large number of capsules fall outside the acceptable weight range, they may need to be reworked or discarded, depending on the nature of the deviation and the production stage.
4. Restart Production
   1. Once the corrective actions are implemented, restart production and monitor capsule weight closely until uniformity is restored. Take additional samples to verify that the problem is resolved.

5.4 Post-Production Review

After completing the production run, perform the following steps:

1. Data Review
   1. Review all the capsule weight data collected during the production run, including individual weights, average weight, and standard deviation. Ensure that all capsules meet the required weight specifications.
2. Documentation
   1. Document the final weight results, including the average weight, standard deviation, and any corrective actions taken. Include this information in the batch production record.

5.5 Equipment Maintenance and Calibration

Ensure that the capsule filling equipment is properly maintained to ensure consistent weight uniformity:

1. Routine Maintenance
   1. Perform routine maintenance on the capsule filling machine, including cleaning, calibration, and inspection of critical components such as the dosing system and weight monitoring equipment.
2. Calibration
   1. Ensure that all measurement equipment, including balances and automated weight monitoring systems, are calibrated regularly according to the manufacturer’s specifications.

5.6 Documentation and Record-Keeping

Ensure thorough documentation of all weight monitoring and corrective actions:

1. Weight Monitoring Records
   1. Document the results of all weight monitoring activities, including the average capsule weight, individual weights, and any deviations observed during the production run.
2. Deviation Reports
   1. Document any deviations from the target weight specifications and the corrective actions taken to resolve them. Include the root cause analysis and any preventive measures implemented.
3. Calibration and Maintenance Records
   1. Maintain records of all equipment calibration and maintenance activities, including the date of calibration, the technician involved, and any corrective actions taken to ensure proper functioning.

6. Abbreviations

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

7. Documents

1. Capsule Weight Monitoring Record (Annexure-1)
2. Deviation Report (Annexure-2)
3. Calibration and Maintenance 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: Capsule Weight Monitoring Record

Batch ID	Capsule Size	Target Weight	Average Weight	Deviation	Operator Name	Production Date
Batch 001	Hard Gelatin	500 mg	505 mg	5% Overfill	John Doe	01/02/2025

Annexure-2: Deviation Report

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

Annexure-3: Calibration and Maintenance Record

Equipment ID	Calibration Date	Technician	Calibration Results
Filling Machine 15	01/02/2025	John Smith	Within Tolerance

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 weight limits	Standardization	QA Head