SOP Guide for Pharma

Capsule: SOP for Validation of Water Systems for Capsule Shell Production – V 2.0

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Capsule: SOP for Validation of Water Systems for Capsule Shell Production – V 2.0

Standard Operating Procedure for Validation of Water Systems for Capsule Shell Production

Department Capsule Manufacturing
SOP No. SOP/CM/173/2025
Supersedes SOP/CM/173/2022
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 define the process for validating water systems used in capsule shell production. The water used in capsule manufacturing must meet specific purity and quality standards to ensure the safety, efficacy, and compliance of the final product. This SOP provides guidelines for validating the water system, including testing for quality, purity, flow rates, and system integrity.

2. Scope

This SOP applies to all water systems used in capsule shell production, including purified water systems, water for injection (WFI) systems, and other water systems necessary for manufacturing processes. It covers the validation of the water system to ensure it meets GMP requirements and the specified quality criteria for use in capsule shell production.

3. Responsibilities

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4. Accountability

The Engineering Supervisor is responsible for ensuring the water system is installed and operational in compliance with the system design specifications. The QA Manager is responsible for reviewing and approving the validation results. The Production Supervisor ensures that water quality is consistently maintained throughout the manufacturing process.

5. Procedure

5.1 Pre-Validation Setup

Before starting the water system validation process, ensure the following steps are completed:

  1. Review Validation Plan
    1. Review the water system validation plan to ensure it includes all required tests, system specifications, and acceptance criteria. The plan must be approved by the QA department before the validation process begins.
  2. Prepare the Water System
    1. Ensure that the water system is installed and configured correctly, including all necessary filtration units, pumps, and piping.
    2. Ensure that the system is properly connected to the production line and that it can deliver the required volume of water to the production areas.
  3. Calibrate Monitoring Instruments
    1. Calibrate all monitoring instruments, such as pressure gauges, flow meters, and conductivity meters, used to measure water quality and flow rates. Record calibration details in the Equipment Calibration Log (Annexure 1).

5.2 Performance Qualification (PQ) Testing

Perform the following tests to validate the water system’s performance:

  1. Verify Water Quality
    1. Perform microbiological tests (e.g., total bacterial count, endotoxin testing) and chemical tests (e.g., pH, conductivity, TDS) on the water to ensure it meets the specified purity criteria.
    2. Test the water for common contaminants, including particulates, metals, and microbial contamination. Document all test results in the Performance Qualification Log (Annexure 2).
  2. Verify Flow Rates
    1. Measure the flow rate of the water system at various points, ensuring that the system can meet the required flow specifications for production demands.
  3. Test System Integrity
    1. Check for leaks, pressure fluctuations, and other issues that could affect the performance of the water system. Ensure that the system maintains stable pressure and flow rates over time.
  4. Verify Alarm Systems
    1. Test the system’s alarm functions to ensure that any deviation from normal operating conditions (e.g., pressure loss, contamination) triggers an appropriate alarm and takes corrective action.
  5. Document PQ Results
    1. Document all results of the PQ testing in the PQ Report (Annexure 3). If any deviations are found, investigate the cause, take corrective actions, and re-test the system until it meets the specifications.
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5.3 Post-Qualification Activities

Once the PQ tests are completed, the following activities should be completed:

  1. System Integration into Production
    1. Integrate the validated water system into regular production operations, ensuring that water quality is consistently maintained during production runs.
  2. Operator Training
    1. Provide training for operators on how to monitor the water system’s performance during production. Operators should be trained on how to handle alarms and take corrective actions if necessary.
  3. Sign-Off and Approval
    1. Once validation is complete, the QA Manager should sign off on the validation process. Ensure that all documentation is completed and filed for record-keeping.

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6. Abbreviations

7. Documents

  1. Annexure 1: Equipment Calibration Log
  2. Annexure 2: Performance Qualification Log
  3. Annexure 3: Performance Qualification Report

8. References

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
Water System 103 01/02/2025 John Doe Calibration of flow meters and pressure gauges 01/02/2026

Annexure 2: Performance Qualification Log

Batch ID PQ Date Operator Test Type Results
Batch 001 02/02/2025 Jane Smith Water Quality Test Pass

Annexure 3: Performance Qualification Report

Batch ID Test Date Test Type Results Remarks
Batch 001 02/02/2025 Water System Test Pass System passed all tests for quality and flow rates

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 water system validation in capsule manufacturing QA Head
01/02/2025 2.0 Updated testing criteria and added new system checks Improvement of validation tests and inclusion of updated requirements QA Head
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