Document ID: DQ-OPHT-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Ophthalmic Holding Tank
This document outlines the Design Qualification (DQ) protocol for the Ophthalmic Holding Tank utilized in the production of sterile eye drops and ointments.
Objective: To establish a validated design qualification for the Ophthalmic Holding Tank ensuring it meets the specified requirements for holding sterile bulk before filling.
Scope: This protocol applies to the Ophthalmic Holding Tank located in the production area, focusing on its critical parameters affecting product quality.
Responsibilities:
- Validation Team: Execute and document the DQ protocol.
- Quality Assurance: Review and approve the DQ documentation.
- Production Team: Provide operational input and support during testing.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be performed prior to DQ.
- Training of personnel on equipment operation and validation processes.
Equipment Description:
The Ophthalmic Holding Tank is a sterile, pressurized tank designed to hold sterile bulk products before filling into final containers. The tank is equipped with a pressure hold vent filter to maintain sterility and prevent contamination.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify pressure hold integrity | Pressure remains stable within specified range | Pressure log records |
| DQ-002 | Check vent filter integrity | No breaches or leaks detected | Filter integrity test results |
| DQ-003 | Temperature monitoring | Temperature remains within specified limits | Temperature log records |
Detailed Test Cases:
- Test Case DQ-001: Monitor and log pressure for a minimum of 24 hours. Acceptable range: [Insert Range].
- Test Case DQ-002: Conduct a bubble point test on the vent filter to confirm integrity.
- Test Case DQ-003: Record temperature at regular intervals to ensure compliance with specified limits.
Deviations: Any deviations from the acceptance criteria must be documented and reviewed by the Quality Assurance team for impact assessment.
Approvals:
- Validation Team Lead: [Insert Name] – Signature: _______________ Date: _______________
- Quality Assurance Manager: [Insert Name] – Signature: _______________ Date: _______________
Data Integrity Checks:
- Automated logging of pressure and temperature readings to prevent manual entry errors.
- Regular audits of log records to ensure compliance with data integrity standards.