Document Control
Document ID: DQ-WS-PU-LVP-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Design Qualification Protocol for Water System (PW/WFI) – Point of Use for LVP
Meta Description: This document outlines the Design Qualification Protocol for the Water System (PW/WFI) utilized for LVP/SVP in pharmaceutical compounding, ensuring compliance with regulatory standards.
Tags: Equipment Validation, Water System, IV Infusions, Pharmaceutical Compliance
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Water System (PW/WFI) at the Point of Use for LVP meets the specified requirements and is suitable for its intended use in compounding and cleaning in place (CIP) processes.
Scope
This protocol applies to the Water System (PW/WFI) utilized for the preparation of LVP/SVP in the pharmaceutical manufacturing area. It covers the validation of equipment critical to maintaining the quality of water used in compounding.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Operations: Responsible for ensuring the equipment is maintained and operated according to established procedures.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) completed and approved.
- Access to relevant SOPs and regulatory guidelines (Annex 11, Annex 15).
Equipment Description
The Water System (PW/WFI) is designed to provide purified water for compounding and cleaning processes. It includes filtration, reverse osmosis, and storage components, with a Point of Use system ensuring water quality at the dispensing point.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Conductivity Measurement | Conductivity ≤ 1.3 µS/cm | Conductivity log sheets |
| T2 | TOC Analysis | TOC ≤ 500 ppb | TOC test results |
| T3 | Microbial Testing | No growth in 100 mL | Microbial test results |
| T4 | Temperature Audit Trail Review | Temperature maintained within 20-25°C | Temperature logs |
Detailed Test Cases
Test Case 1: Conductivity Measurement
Procedure: Measure the conductivity of the PW/WFI at the Point of Use using a calibrated conductivity meter. Record the results.
Acceptance Criteria: Conductivity must be ≤ 1.3 µS/cm.
Evidence: Conductivity log sheets must be maintained and reviewed.
Test Case 2: TOC Analysis
Procedure: Collect a sample of PW/WFI and analyze for Total Organic Carbon (TOC) using a calibrated TOC analyzer.
Acceptance Criteria: TOC must be ≤ 500 ppb.
Evidence: TOC test results must be documented.
Test Case 3: Microbial Testing
Procedure: Perform microbial testing on a 100 mL sample of PW/WFI using appropriate microbiological methods.
Acceptance Criteria: No growth should be observed.
Evidence: Microbial test results must be recorded.
Test Case 4: Temperature Audit Trail Review
Procedure: Review the temperature audit trail data for the Water System to ensure compliance with temperature requirements.
Acceptance Criteria: Temperature must be maintained within 20-25°C.
Evidence: Temperature logs must be available for review.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented as necessary.
Approvals
This protocol requires approval from the Validation Team, Quality Assurance, and Operations prior to execution.