Document Control
Protocol Number: OQ-PW-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Operational Qualification Protocol for Purified Water Generation System
Meta Description: This document outlines the Operational Qualification protocol for the Purified Water Generation System, ensuring compliance with regulatory standards.
Tags: Equipment Validation, OQ, Purified Water, Utilities, Pharmaceutical
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Purified Water Generation System (PW System) operates within established parameters, ensuring the generation of purified water that meets quality standards.
Scope
This protocol applies to the Purified Water Generation System utilized in the Utilities area for generating purified water, impacting product quality directly.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Operations: Responsible for maintaining the equipment in accordance with the protocol.
Prerequisites
- Completion of Equipment Installation Qualification (IQ).
- Availability of all necessary documentation and standard operating procedures (SOPs).
- Training of personnel on the operation of the PW System.
Equipment Description
The Purified Water Generation System is designed to produce purified water for pharmaceutical manufacturing, ensuring compliance with regulatory standards. Key critical parameters include conductivity, TOC, flow, temperature, pressure, and audit trail.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Measure Conductivity | Conductivity ≤ 1.3 µS/cm | Conductivity log |
| OQ-002 | Measure TOC | TOC ≤ 500 ppb | TOC report |
| OQ-003 | Measure Flow Rate | Flow rate within specified range (e.g., 1-10 L/min) | Flow rate log |
| OQ-004 | Measure Temperature | Temperature maintained at 20-25°C | Temperature log |
| OQ-005 | Measure Pressure | Pressure within specified range (e.g., 10-15 psi) | Pressure log |
| OQ-006 | Audit Trail Verification | Audit trail logs must be complete and accurate | Audit trail report |
Detailed Test Cases
OQ-001: Measure Conductivity
Procedure: Use a calibrated conductivity meter to measure the conductivity of the output water. Record the value.
OQ-002: Measure TOC
Procedure: Collect a sample of the purified water and analyze for TOC using a validated method. Record the TOC value.
OQ-003: Measure Flow Rate
Procedure: Measure the flow rate of the purified water using a calibrated flow meter. Record the value.
OQ-004: Measure Temperature
Procedure: Use a calibrated thermometer to measure the temperature of the purified water. Record the value.
OQ-005: Measure Pressure
Procedure: Use a calibrated pressure gauge to measure the pressure within the system. Record the value.
OQ-006: Audit Trail Verification
Procedure: Review the audit trail logs for completeness and accuracy. Document any discrepancies.
Deviations
Any deviations from the acceptance criteria must be documented and justified. Corrective actions should be implemented as necessary.
Approvals
This protocol requires approval from the Validation Team, Quality Assurance, and Operations before execution.