Document Control
Document ID: DQ-TP-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared by: Validation Team
Approved by: QA Manager
Design Qualification Protocol for Sanitary Transfer Pump
Meta Description: This document outlines the Design Qualification protocol for the Sanitary Transfer Pump used in the production of nasal and otic products, focusing on critical parameters and acceptance criteria.
Tags: Equipment Validation, Design Qualification, Sanitary Transfer Pump, Production, Nasal Products, Otic Products
Objective
The objective of this Design Qualification (DQ) protocol is to establish the requirements and acceptance criteria for the Sanitary Transfer Pump used in the production of nasal and otic products, ensuring compliance with regulatory standards and product specifications.
Scope
This protocol applies to the validation of the Sanitary Transfer Pump utilized in the transfer of sterile and non-sterile solutions within the production area.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance (QA): Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for the operation and maintenance of the Sanitary Transfer Pump.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation of the Sanitary Transfer Pump in the designated production area.
- Training of personnel on the operation of the Sanitary Transfer Pump.
Equipment Description
The Sanitary Transfer Pump is designed for the transfer of sterile and non-sterile solutions, ensuring shear seal integrity and maintaining appropriate flow rates. The equipment is critical for the production of nasal and otic products due to its direct impact on product quality.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-TP-01 | Verify flow rate at specified settings. | Flow rate within specified limits. | Flow rate measurement logs. |
| DQ-TP-02 | Check seal integrity under operational conditions. | No leaks observed during operation. | Seal integrity test results. |
Detailed Test Cases
Test Case 1: Verify Flow Rate
Objective: Ensure the pump meets specified flow rate.
Procedure: Operate the pump at different settings and measure the flow rate using calibrated equipment.
Acceptance Criteria: Flow rate must be within the limits specified in the URS.
Evidence: Documented flow rate measurements and comparison against URS.
Test Case 2: Check Seal Integrity
Objective: Confirm that the shear seal maintains integrity during operation.
Procedure: Run the pump under normal operational conditions and inspect for leaks.
Acceptance Criteria: No leaks should be present during the operational test.
Evidence: Inspection logs and photographs of the pump during operation.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Appropriate corrective actions must be taken and documented.
Approvals
The DQ protocol and results shall be reviewed and approved by the QA Manager prior to the use of the Sanitary Transfer Pump in production.