Capsule: SOP for Using Automated Weighing Systems – V 2.0

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Capsule: SOP for Using Automated Weighing Systems – V 2.0

Standard Operating Procedure for Using Automated Weighing Systems

Department Production
SOP No. SOP/PROD/007/2025
Supersedes SOP/PROD/007/2022
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 procedures for using automated weighing systems in capsule manufacturing. This ensures accurate measurement of ingredients, compliance with GMP (Good Manufacturing Practices), and maintains consistency in the production process.

2. Scope

This SOP applies to all automated weighing systems used in capsule production for measuring raw materials, excipients, and active pharmaceutical ingredients (APIs).

3. Responsibilities

  • Production Operators: Responsible for operating automated weighing systems and ensuring they are calibrated and functioning properly during the production process.
  • Maintenance Team: Responsible for performing routine maintenance and troubleshooting of the automated weighing systems to ensure their proper operation.
  • Quality Assurance (QA) Team: Responsible for verifying that the automated weighing systems are calibrated, performing correctly, and compliant with GMP standards.
  • Production Supervisor: Ensures that the procedures outlined in this SOP are followed and verifies that the automated weighing systems are functioning as intended throughout the production process.

4. Accountability

The Production Supervisor is accountable for ensuring that automated weighing systems are used according to the SOP. The QA team is responsible for verifying that the system is calibrated and meets GMP standards.

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5. Procedure

5.1 Preparation for Weighing

Before using the automated weighing system, ensure the following steps are completed:

  1. Verify System Calibration

    1. Check the calibration certificate to ensure the automated weighing system is within the acceptable limits.
    2. Perform a calibration check using certified calibration weights if the last calibration is due for review.
  2. Check Equipment Setup

    1. Ensure the weighing system is set up correctly, including any relevant software or hardware configurations.
    2. Verify that the system is connected to any necessary peripheral devices (e.g., printers, data recorders, etc.).
  3. Prepare Weighing Materials

    1. Ensure that all containers or equipment to hold the ingredients are clean, dry, and free of contaminants.
    2. Ensure that the raw materials or ingredients to be weighed are properly labeled and ready for use.

5.2 Weighing Process

Follow these steps to ensure proper weighing:

  1. Initiate the Weighing System

    1. Turn on the automated weighing system and ensure it is functioning properly with no error messages.
    2. Select the appropriate weighing mode or preset for the material being weighed.
  2. Place the Material on the Weighing Scale

    1. Place the material to be weighed on the scale according to the system’s preset instructions.
    2. Ensure the weight is automatically recorded and that it falls within the acceptable range.
  3. Confirm Weighing Accuracy

    1. Verify that the weight displayed by the automated weighing system matches the expected value.
    2. Record the weight value and confirm that it is within the acceptable tolerance limits set by the SOP or formula specifications.
  4. Store the Weighing Data

    1. Save the weighing data in the system’s database or print the weight log for documentation purposes.
    2. Ensure that all relevant information (e.g., batch number, operator ID, time of weighing) is included in the data records.
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5.3 Post-Weighing Procedures

After weighing is completed, follow these steps:

  1. Remove Materials and Clean the Equipment

    1. Remove the weighed material from the scale and store it in the appropriate container.
    2. Clean the automated weighing system, removing any residue or spillage that may have occurred during the weighing process.
  2. Verify Documentation

    1. Ensure that all weighing data is recorded properly in the batch manufacturing records (BMRs) or electronic records.
    2. Check the documentation for accuracy and completeness, including all details such as material type, weight, operator, and date.

5.4 Maintenance and Troubleshooting

If issues arise with the automated weighing system, perform the following steps:

  1. Troubleshooting

    1. If the system displays errors, refer to the troubleshooting guide or manual to identify and resolve the issue.
    2. If the system cannot be fixed quickly, report the issue to the Maintenance Team for further investigation.
  2. Schedule Maintenance

    1. Schedule periodic maintenance of the automated weighing system to ensure its continued accuracy and functionality.
    2. Ensure that maintenance logs are kept for all maintenance activities performed.
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5.5 Documentation and Recordkeeping

Ensure that all weighing activities are documented as follows:

  1. Weighing Logs

    1. Maintain a record of all weighing activities, including the weight values, batch numbers, operator details, and any discrepancies observed during weighing (refer to Annexure 1).
  2. Audit Trail

    1. Ensure that all records are stored for the required retention period and are available for internal or external audits.

6. Abbreviations

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

7. Documents

  1. Annexure 1: Weighing Log Template

8. References

  • Good Manufacturing Practice (GMP) Guidelines
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure 1: Weighing Log Template

Equipment ID Weighing Date Operator Name Material Weight Approval
Filling Machine 01 02/03/2025 John Doe API X 50 kg Approved

12. Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version of SOP Creation of SOP for automated weighing system QA Head
01/02/2025 2.0 Added documentation and validation steps Improved procedures for weight tracking and validation QA Head
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