Capsule: SOP for Online Weight Monitoring of Capsules – V 2.0

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Capsule: SOP for Online Weight Monitoring of Capsules – V 2.0

Standard Operating Procedure for Online Weight Monitoring of Capsules

Department Capsule Manufacturing
SOP No. SOP/CM/096/2025
Supersedes SOP/CM/096/2022
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 define the process for online weight monitoring of capsules during manufacturing. The goal is to ensure that capsules are filled with the correct amount of active ingredient and excipient, maintaining consistent quality and regulatory compliance.

2. Scope

This SOP applies to all capsule production processes where online weight monitoring is performed. It includes the procedures for setting up, calibrating, and operating the online weight monitoring system to ensure accurate weight measurement during the manufacturing process.

3. Responsibilities

  • Production Operators: Responsible for operating the online weight monitoring system and ensuring the weight of capsules is within the specified limits.
  • Quality Control (QC) Team: Responsible for monitoring the results from the online weight monitoring system and conducting checks to ensure the accuracy of measurements.
  • Quality Assurance (QA) Team: Ensures compliance with the SOP, reviews the weight data, and oversees corrective actions if deviations are observed.
  • Production Supervisor: Oversees the entire weight monitoring process and ensures that it is performed correctly and in compliance with regulatory standards.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the online weight monitoring system is properly set up, calibrated, and operated according to this SOP. The QA Manager is responsible for reviewing the results and taking corrective actions when necessary.

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5. Procedure

5.1 Setting Up the Online Weight Monitoring System

Before beginning the capsule manufacturing process, ensure that the weight monitoring system is properly set up:

  1. Calibration

    1. Calibrate the online weight monitoring system to ensure accurate weight measurements. Follow the manufacturer’s calibration procedures and use certified calibration weights.
    2. Verify that the system is accurately measuring the weight of capsules by running test capsules through the system and comparing the results to a known reference.
  2. Set Weight Limits

    1. Set the acceptable weight limits for capsules according to the product specifications. These limits should account for the tolerances of the manufacturing process and regulatory requirements.
  3. System Integration

    1. Integrate the online weight monitoring system with the capsule filling machine and ensure that the system is continuously tracking the weight of capsules during production.

5.2 Monitoring Capsule Weight During Production

Once the system is set up, the following steps should be taken to monitor the weight of capsules during production:

  1. Continuous Monitoring

    1. Continuously monitor the weight of capsules as they are being filled. The online weight monitoring system should capture data in real-time, providing feedback on any variations in weight.
    2. The system should be capable of identifying any out-of-specification capsules and triggering an alert if the weight falls outside the specified limits.
  2. Recording the Data

    1. The system should automatically record the weight data for each batch of capsules produced, including the average weight, highest and lowest weight, and any deviations from the set limits.
    2. Ensure that all weight data is saved and can be retrieved for future analysis and audits.
  3. Weight Deviations

    1. If any capsules are found to be outside the acceptable weight range, the system should flag these capsules and notify the operator immediately.
    2. The operator should isolate the affected capsules for further investigation and corrective action.
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5.3 Investigating Weight Deviations

If deviations from the expected weight range are detected, the following steps should be followed:

  1. Investigate Equipment Issues

    1. Check the capsule filling machine to ensure that it is calibrated correctly and that there are no issues with the equipment that could affect the weight of the capsules.
    2. Look for signs of malfunctions such as uneven filling, equipment wear, or issues with the capsule molds that could result in inconsistent weights.
  2. Review Raw Material Quality

    1. Investigate the quality of the raw materials used in the capsule filling process, as variations in material properties can affect capsule weight.
    2. Check the excipients and active pharmaceutical ingredients (APIs) for consistency and batch-to-batch variation.
  3. Inspect Operator Practices

    1. Review the operator’s procedures and ensure they are correctly following the prescribed filling process, including proper handling of materials and equipment settings.
  4. Take Corrective Actions

    1. Implement corrective actions to address the root cause of the deviation, such as recalibrating the filling equipment, adjusting material handling procedures, or retraining operators.

5.4 Documenting Weight Monitoring Results

Accurate documentation is essential for traceability and compliance:

  1. Maintain Weight Monitoring Records

    1. Document all weight monitoring results, including the average weight, highest and lowest weight, and any deviations from the set weight limits.
    2. Record any corrective actions taken in response to deviations and ensure that the data is saved for future reference.
  2. Report Deviations

    1. Any deviations outside of the acceptable weight range should be documented in the Deviation Log (Annexure-1), including the investigation and corrective actions taken.

5.5 Final Approval for Packaging

Once weight monitoring is complete, the following steps should be taken before the capsules are approved for packaging:

  1. QA Review

    1. The QA team should review the weight monitoring data to ensure that all capsules are within the acceptable weight range and that no deviations remain unaddressed.
  2. Approval for Packaging

    1. If the weight monitoring results meet the required standards, the batch can be approved for packaging and labeling.
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6. Abbreviations

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

7. Documents

  1. Capsule Weight 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

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Capsule Weight Monitoring Log

Batch ID Weight Monitoring Data Deviation Found Corrective Action Operator Name
Batch 001 Average weight: 350 mg, Lowest weight: 348 mg, Highest weight: 352 mg No None John Doe

Annexure-2: Deviation Log

Deviation ID Description Corrective Action Taken Operator Name Approval Status
DEV-001 Capsules outside acceptable weight range Adjusted filling machine settings and recalibrated the weight monitoring system Jane Smith Approved

Annexure-3: Batch Production Record (BPR)

Batch ID Production Date Capsules Produced Weight Monitoring 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 weight monitoring process and corrective actions Standardization QA Head
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