Document Control
Document Number: DQ-PW-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Parts Washer in Solid Dosage Form Equipment Validation
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Parts Washer (GMP) is designed, installed, and operates in compliance with the requirements specified in the User Requirements Specification (URS) Annex 11.
Scope
This protocol applies to the Parts Washer used in the production and cleaning of equipment parts in the Solid Dosage Form (OSD) manufacturing area.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Team: Responsible for the overall validation process.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for equipment installation and maintenance.
Prerequisites
- Completion of the User Requirements Specification (URS).
- Installation of the Parts Washer (GMP) in the designated area.
- Availability of qualified personnel for conducting tests.
Equipment Description
The Parts Washer (GMP) is designed to wash equipment parts used in the Solid Dosage Form production process. It operates under controlled conditions to ensure effective cleaning and sanitization.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-T1 | Verify wash temperature | Temperature maintained within specified range | Temperature log |
| DQ-T2 | Verify wash time | Time meets specified duration | Time log |
| DQ-T3 | Verify wash pressure | Pressure within acceptable limits | Pressure readings |
| DQ-T4 | Verify detergent dosing | Correct amount of detergent used | Dosing records |
| DQ-T5 | Verify PLC functionality | PLC operates as intended | PLC test results |
Detailed Test Cases
Test Case: Verify Wash Temperature
Objective: To ensure the wash temperature is maintained within the specified range during operation.
Procedure: Monitor the temperature readings throughout the wash cycle.
Acceptance Criteria: Temperature must remain within the defined limits.
Evidence: Documented temperature logs.
Test Case: Verify Wash Time
Objective: To confirm that the wash time meets the specified duration.
Procedure: Track the duration of the wash cycle.
Acceptance Criteria: Time must meet or exceed the specified duration.
Evidence: Time log documentation.
Test Case: Verify Wash Pressure
Objective: To ensure wash pressure is within acceptable limits.
Procedure: Measure the pressure during the wash cycle.
Acceptance Criteria: Pressure must be within defined limits.
Evidence: Recorded pressure readings.
Test Case: Verify Detergent Dosing
Objective: To validate the correct amount of detergent is used during the wash cycle.
Procedure: Check the detergent dosing mechanism for accuracy.
Acceptance Criteria: Dosing must match specified requirements.
Evidence: Dosing records.
Test Case: Verify PLC Functionality
Objective: To ensure the PLC operates correctly during the wash cycle.
Procedure: Test the PLC controls and outputs.
Acceptance Criteria: PLC must function as intended.
Evidence: PLC test results documentation.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on the validation process. A deviation report should be generated and approved by the Quality Assurance team.
Approvals
This Design Qualification Protocol must be reviewed and approved by the following personnel:
- Validation Team Lead: [Insert Name]
- Quality Assurance Manager: [Insert Name]
- Engineering Lead: [Insert Name]