Standard Operating Procedure for IQ/OQ/PQ of Water Purification Systems (RO, WFI)
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying Water Purification Systems, including Reverse Osmosis (RO) and Water for Injection (WFI) systems, used in pharmaceutical manufacturing. This SOP ensures that the water purification systems are correctly installed, calibrated, and operate according to the required specifications. The qualification process verifies that these systems provide the required water quality (RO and WFI) to meet the specifications for use in drug manufacturing while ensuring compliance with regulatory standards.
2) Scope
This SOP applies to the qualification of Water Purification Systems, including Reverse Osmosis (RO) systems and Water for Injection (WFI) systems, used in pharmaceutical manufacturing. The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This SOP is applicable to both new water purification systems and those that have undergone significant repairs, upgrades, or relocations. The qualification ensures that the systems meet the required water quality standards and operate consistently and reliably under the conditions specified in the manufacturer’s guidelines and regulatory requirements.
3) Responsibilities
Operators: Responsible for assisting in the IQ, OQ, and PQ processes, ensuring
Quality Assurance (QA): Ensures that the IQ, OQ, and PQ of the Water Purification Systems are carried out in compliance with this SOP and meet all regulatory requirements. QA is responsible for reviewing and approving all qualification reports and documentation.
Production Supervisors: Oversee the qualification processes to ensure that operators follow the protocol and that the Water Purification Systems operate within the specified parameters.
Validation Team: Responsible for developing the qualification protocols, executing the IQ, OQ, and PQ runs, and analyzing the results to ensure the Water Purification Systems meet all performance criteria.
Maintenance Personnel: Ensures that the Water Purification Systems are properly installed, maintained, and calibrated, and that all mechanical and electrical systems are functioning correctly during the qualification process.
4) Procedure
The following steps should be followed for the IQ, OQ, and PQ of Water Purification Systems (RO, WFI):
1. Installation Qualification (IQ):
1.1 Review the Water Purification System specifications and manufacturer manuals to ensure that the equipment meets the necessary installation requirements.
1.2 Verify that all required utilities (e.g., electrical power, water supply, and chemical additives) are available and meet the specifications required for operation.
1.3 Ensure that the installation site meets the required environmental conditions such as temperature, humidity, and space.
1.4 Confirm that all mechanical components are correctly installed, including membranes, pumps, storage tanks, piping, filters, and the necessary valves.
1.5 Ensure that all electrical components, including controllers, sensors, and data loggers, are correctly connected and functioning.
1.6 Perform a visual inspection to confirm that the Water Purification System is installed according to the manufacturer’s instructions and that all components are intact.
1.7 Complete the IQ documentation, including checklists, equipment manuals, and relevant installation records, ensuring that all information is recorded and signed off by responsible personnel.
2. Operational Qualification (OQ):
2.1 Verify that all operational controls, such as water temperature, flow rate, pressure, and filtration, are properly set and calibrated.
2.2 Conduct a dry run of the Water Purification System to verify that it operates without issues. Monitor key parameters such as flow rate, pressure, and water quality (e.g., conductivity, total organic carbon (TOC), endotoxins).
2.3 Test all control systems, ensuring that the system maintains the required pressure, flow, and quality during operation.
2.4 Inspect the Water Purification System to ensure that it meets the specified water quality standards (e.g., WFI, RO water) and performs within the specified parameters.
2.5 Verify that the system can maintain the required quality of water (including TOC, conductivity, microbial levels) under typical operational conditions.
2.6 Document the results of the OQ, noting any deviations or issues encountered and corrective actions taken.
3. Performance Qualification (PQ):
3.1 Conduct the operation of the Water Purification System under typical production conditions to monitor its performance during routine use.
3.2 Verify that the Water Purification System consistently produces the required water quality, including RO and WFI quality, under varying load conditions.
3.3 Measure and record the parameters for water quality such as conductivity, TOC, endotoxins, and microbial load at various points in the system.
3.4 Verify that the Water Purification System consistently performs within the acceptable ranges for water quality over extended periods.
3.5 Conduct testing to ensure that the system effectively removes contaminants, including microbial load and endotoxins, from the water.
3.6 Document the results of the PQ, including all water quality test results, performance data, and any deviations. Ensure that all records are signed and reviewed by responsible personnel.
4. Documentation and Reporting:
4.1 Record all data during the IQ, OQ, and PQ processes, including system logs, water quality testing results, process parameters, and inspection results.
4.2 Ensure that all forms, reports, and certificates are completed and signed by responsible personnel.
4.3 Perform statistical analysis on the collected data to assess the consistency and reliability of the Water Purification System. This analysis should confirm that the system operates consistently within predefined parameters and meets the acceptance criteria for water quality.
4.4 Prepare a final qualification report, summarizing the results of the IQ, OQ, and PQ, including any deviations, corrective actions, and conclusions regarding the Water Purification System’s performance.
5. Requalification:
5.1 Requalify the Water Purification System if significant changes are made to the equipment, such as replacing major components, relocating the system, or modifying the filtration or membrane systems.
5.2 Periodically perform requalification to ensure that the system continues to perform as expected and remains in compliance with regulatory requirements.
5) Abbreviations
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- TOC: Total Organic Carbon
- WFI: Water for Injection
- RO: Reverse Osmosis
6) Documents
- IQ/OQ/PQ Protocol
- Water Purification System Manufacturer Specifications
- Installation and Setup Reports
- Calibration Records
- Water Quality Logs (Conductivity, TOC, Endotoxins)
- Endotoxin and Microbial Testing Logs
- Deviation and Corrective Action Reports
7) Reference
- FDA Guidance for Industry: Equipment Qualification
- International Council for Harmonisation (ICH) Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- ISO 9001: Quality Management Systems – Requirements
- USP Chapter 1231: Water for Pharmaceutical Purposes
- USP Chapter 1691: Water for Injection (WFI) – Monographs
8) SOP Version
Version 1.0 – Effective Date: DD/MM/YYYY
Annexure
Template 1: IQ/OQ/PQ Test Record
| Date | Time | Operator Initials | Test Type (IQ/OQ/PQ) | Test Results | Comments |
|---|---|---|---|---|---|
| DD/MM/YYYY | HH:MM | Operator Name | IQ/OQ/PQ | Pass/Fail | Comments |
Template 2: Water Quality Log
| Batch No. | Test Date | Conductivity (μS/cm) | TOC (ppb) | Endotoxin (EU/mL) | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Conductivity | TOC | Endotoxin | Operator Name |
Template 3: Endotoxin and Microbial Test Log
| Batch No. | Test Date | Microbial Load (CFU/mL) | Endotoxin Level (EU/mL) | Pass/Fail | Operator Initials |
|---|---|---|---|---|---|
| Batch Number | DD/MM/YYYY | Microbial Load | Endotoxin Level | Pass/Fail | Operator Name |