Standard Operating Procedure for Validation of Capsule Weight Monitoring Equipment
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/169/2025 |
| Supersedes | SOP/CM/169/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to provide guidelines for validating capsule weight monitoring equipment used in the capsule manufacturing process. Weight monitoring equipment is essential for ensuring that each capsule meets the specified weight criteria and that the production process remains compliant with GMP standards. This SOP ensures that the equipment is calibrated, operates accurately, and provides consistent measurements during production.
2. Scope
This SOP applies to all capsule weight monitoring equipment used in the capsule production process. It covers the validation procedures, including the calibration, operational checks, and documentation necessary to verify that the equipment performs within the specified operational limits.
3. Responsibilities
- Engineering Team: Responsible for installing, setting up, and calibrating the weight monitoring equipment, and performing equipment checks as outlined in this SOP.
- Quality Control (QC) Team: Responsible for conducting performance checks on the weight monitoring equipment, verifying calibration, and documenting the results of the validation process.
- Quality Assurance (QA) Team: Responsible for reviewing and approving the validation documentation to ensure compliance with GMP and regulatory standards.
- Production Team: Ensures that the equipment is correctly integrated into the production line and that the capsules are properly weighed and monitored during production.
4. Accountability
The Engineering Supervisor is responsible for ensuring that the weight monitoring equipment is installed, calibrated, and operational. The QA Manager is responsible for reviewing and approving the validation process and ensuring compliance with GMP and regulatory standards. The Production Supervisor is responsible for ensuring the weight monitoring system is fully functional during production.
5. Procedure
5.1 Pre-Validation Setup
Before starting the validation process, ensure the following preparations are completed:
-
Review Validation Plan
- Review the validation plan to ensure it includes all the necessary steps, equipment specifications, calibration criteria, and acceptance criteria. The plan should be approved by the QA department before initiating validation.
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Prepare the Equipment
- Ensure that the weight monitoring equipment is installed and properly connected to the production line. Verify that it is linked to the system used for recording and reporting capsule weights.
- Ensure that the equipment is clean and free from any debris that could affect its operation.
-
Calibrate the Equipment
- Calibrate the weight monitoring equipment according to the manufacturer’s specifications. This includes calibrating the scales, sensors, and software used for weight measurement.
- Record the calibration details in the Equipment Calibration Log (Annexure 1).
5.2 Performance Qualification (PQ) Testing
Follow these steps to perform the operational qualification of the capsule weight monitoring equipment:
-
Test Weight Monitoring Accuracy
- Use standard test weights to verify the accuracy of the equipment. Compare the measured weight with the standard weight and ensure that the equipment is within the specified tolerance limits.
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Verify Weight Measurement Consistency
- Perform multiple tests on the same test weight to verify that the equipment provides consistent measurements over time. Document the test results in the Validation Log (Annexure 2).
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Test Performance During Production Conditions
- Run a test during a production run to verify that the weight monitoring system is capable of accurately measuring capsule weights under actual production conditions.
- Ensure that the equipment accurately detects variations in capsule weight and rejects out-of-specification capsules.
-
Verify Alarm and Alert System
- Test the alarm system to ensure that it activates when the weight of a capsule is outside the acceptable range. Ensure the system correctly rejects the defective capsules and logs the event for further investigation.
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Document Performance Results
- Document the results of all performance tests and ensure the equipment meets the acceptance criteria. If deviations are observed, investigate the cause and take corrective actions. Re-test until the equipment meets all specifications.
5.3 Post-Qualification Activities
After the validation process is completed, ensure the following tasks are completed:
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Operator Training
- Train operators on the proper use of the weight monitoring system, including how to interpret weight data, perform basic troubleshooting, and handle alarms.
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Sign-Off and Approval
- Ensure that the validation process is completed successfully, and the weight monitoring equipment is signed off for use in production by the QA Manager. The PQ Report should be approved and filed for record-keeping.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- PQ: Performance Qualification
- QA: Quality Assurance
- QC: Quality Control
- PPE: Personal Protective Equipment
7. Documents
- Annexure 1: Equipment Calibration Log
- Annexure 2: Performance Qualification Log
- Annexure 3: Performance Qualification Report
8. References
- FDA Guidelines on Equipment Performance Qualification
- Good Manufacturing Practice (GMP) Guidelines
- USP <1058> – Equipment Qualification
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure 1: Equipment Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Weight Monitor 101 | 01/02/2025 | John Doe | Calibration of weight detection system | 01/02/2026 |
Annexure 2: Performance Qualification Log
| Batch ID | PQ Date | Operator | Test Type | Results |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Jane Smith | Weight Measurement Test | Pass |
Annexure 3: Performance Qualification Report
| Batch ID | Test Date | Test Type | Results | Remarks |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Functional Test | Pass | Machine performed within acceptable weight tolerance |
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 performance qualification of capsule weight monitoring equipment | QA Head |
| 01/02/2025 | 2.0 | Updated testing parameters and added new weight monitoring performance checks | Improvement of testing methods and inclusion of updated requirements | QA Head |