Document Control:
Document Number: DQ-WFI-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Water for Injection (WFI) Generation System
Objective
The objective of this Design Qualification (DQ) Protocol is to establish documented evidence that the Water for Injection (WFI) Generation System is suitable for its intended purpose and meets the specified requirements outlined in the User Requirement Specification (URS), Annex 11, and Annex 15.
Scope
This protocol applies to the validation of the Water for Injection (WFI) Generation System used in the pharmaceutical manufacturing process. It covers the critical parameters impacting product quality and safety.
Responsibilities
The Validation Team is responsible for the execution and documentation of this protocol. The Quality Assurance (QA) department will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ).
- Availability of the Water for Injection (WFI) Generation System.
- Personnel trained in validation procedures.
- Approval from QA for the execution of this DQ.
Equipment Description
The Water for Injection (WFI) Generation System is designed to produce water that meets the standards for WFI as defined in pharmacopeial monographs. The system includes components for purification, storage, and distribution of WFI.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Conductivity Measurement | Conductivity ≤ 1.3 µS/cm | Calibration records |
| T2 | TOC Analysis | TOC ≤ 500 ppb | Analytical report |
| T3 | Microbial Testing | No growth in 100 mL sample | Microbial test report |
| T4 | Temperature Audit Trail | Temperature maintained at ≤ 25°C | Audit trail logs |
Detailed Test Cases
Test Case T1: Conductivity Measurement
Procedure: Measure the conductivity of the WFI using a calibrated conductivity meter. Record the results.
Acceptance Criteria: Conductivity must be ≤ 1.3 µS/cm.
Evidence: Calibration records and measurement logs.
Test Case T2: TOC Analysis
Procedure: Perform TOC analysis on a sample of WFI using a TOC analyzer. Record the results.
Acceptance Criteria: TOC must be ≤ 500 ppb.
Evidence: Analytical report from the TOC analyzer.
Test Case T3: Microbial Testing
Procedure: Conduct microbial testing by incubating a 100 mL sample of WFI. Record any growth.
Acceptance Criteria: No growth should be observed.
Evidence: Microbial test report.
Test Case T4: Temperature Audit Trail
Procedure: Review the temperature audit trail for the WFI storage tank over the past 30 days.
Acceptance Criteria: Temperature must be maintained at ≤ 25°C.
Evidence: Audit trail logs.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and approved by QA prior to proceeding with the next steps in validation.
Approvals
Prepared by: [Insert Name]
Validation Team Lead: [Insert Name]
Quality Assurance: [Insert Name]
“`