system’s performance.

Quality Assurance (QA) Team: Responsible for reviewing and approving the water system qualification process and ensuring that the system complies with GMP and regulatory requirements.

Maintenance Team: Responsible for the ongoing maintenance of the water system, ensuring it operates efficiently and meets the necessary quality standards.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the water system is validated and maintained in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Water System Validation

1. Ensure that the water system has been installed correctly and is fully operational. This includes verifying that all components of the system, including filtration units, pumps, pipes, and tanks, are installed according to the specifications.
2. Review the design specifications of the water system, including the flow rates, capacity, water quality standards (e.g., conductivity, pH, microbial content), and operational parameters. Verify that the system meets the required specifications for the intended use.
3. Ensure that all maintenance, calibration, and operational procedures for the system are up to date.
4. Establish the validation team, which should include representatives from Engineering, Production, and QA teams. Ensure that personnel are trained in water system qualification procedures and standards.
5. Verify that water used in the system is compliant with the necessary standards (e.g., USP, EP) and is free of contaminants, ensuring no adverse impact on product quality.

5.2. Conducting Water System Validation

1. The water system validation should include the following tests to ensure that the system produces water that meets the required quality and operates effectively:
   • Installation Qualification (IQ): Verify that the system has been installed correctly according to design specifications. Ensure that all components, including filtration units and water storage tanks, are functioning as intended and free from defects.
   • Operational Qualification (OQ): Test the operational performance of the system, including verifying flow rates, pressure, and temperature under normal operating conditions. Ensure that the system provides water at the specified flow rate and pressure, and that temperature is within the acceptable range.
   • Performance Qualification (PQ): Perform testing to confirm that the system consistently produces water of the required quality (e.g., conductivity, pH, microbial content). Perform microbial and chemical testing on water samples to verify compliance with specifications. Verify that the system meets water quality standards over the specified production cycles.
   • Contaminant Test: Test for contaminants in the water, including total organic carbon (TOC), microbial levels, and endotoxins. Ensure that all contamination levels are within the acceptable limits for manufacturing requirements.
   • System Integrity Test: Verify that the entire water distribution system is free of leaks and can maintain pressure without loss of performance. Perform leak tests on pipes, joints, and other system components.
2. Record all test results, including measured values, test conditions, and any deviations observed. Document the results in the Water System Qualification Report (Annexure-1).

5.3. Documenting the Qualification Results

1. Document the following information in the Water System Qualification Report (Annexure-1):
   • System ID, model number, and installation location
   • The test methods and equipment used for qualification
   • The results of each test performed, including water quality results (e.g., TOC, pH, microbial levels), flow rates, and pressure readings
   • The name and signature of the personnel performing the qualification tests
   • Approval signatures from the QA team
2. Ensure that the qualification report is signed by the responsible personnel and reviewed by the QA team for completeness and accuracy.

5.4. Reviewing and Approving the Qualification Report

1. The QA team should review the Water System Qualification Report to ensure that the system meets all operational and quality requirements, and that it consistently produces water that meets the necessary standards.
2. If any deviations are identified during the qualification process, they should be documented in the Deviation Log (Annexure-2), and corrective actions should be taken. Ensure that all deviations are addressed before approval.
3. The QA team should approve the report once all qualification activities are complete and any deviations have been addressed.

5.5. Finalizing the Qualification Process

1. Once the water system has been successfully validated, it is considered qualified and ready for use in the aerosol manufacturing process. The system can now be used for production activities.
2. All documentation, including the Water System Qualification Report, Deviation Log, and any corrective actions, should be archived for future audits and inspections.
3. Periodic requalification of the water system should be scheduled as needed to ensure continued compliance with regulatory requirements and system performance standards.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• OQ: Operational Qualification
• PQ: Performance Qualification
• IQ: Installation Qualification

7. Documents

1. Water System Qualification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action Log (Annexure-3)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• USP <1231> Water for Pharmaceutical Purposes

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Water System Qualification Report

System ID	Model Number	Serial Number	Test Date	Test Type	Result
WS-001	Model A	SN123456	06/02/2025	Purity Test	Pass
WS-001	Model A	SN123456	06/02/2025	Flow Rate Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	High microbial count in water sample	Replaced filtration system	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Replaced water filtration units	Rajesh Patel	06/02/2025

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated water system validation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures