Design Qualification Protocol for Perforated Pan Coater
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) protocol is to establish the requirements and criteria for the validation of the Auto Coating Pan (Perforated Pan Coater) used in the film coating process for solid dosage forms.
Scope
This protocol applies to the Auto Coating Pan utilized in the production and coating area for solid dosage forms. It covers the validation of equipment criticality, parameters, and acceptance criteria as per URS Annex 11.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol.
- Production Team: Responsible for providing necessary equipment operation data.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) of the equipment.
- Availability of all necessary documentation and equipment manuals.
Equipment Description
The Auto Coating Pan (Perforated Pan Coater) is designed for the film coating of solid dosage forms. It operates by applying a coating solution to the surface of the tablets or pellets while ensuring uniformity and quality of the coating.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify inlet/exhaust temperature settings. | Temperature within specified limits. | Calibration certificates. |
| DQ-001-02 | Check spray rate functionality. | Spray rate matches defined specifications. | Operational data logs. |
| DQ-001-03 | Evaluate pan speed consistency. | Pan speed remains stable during operation. | Speed measurement records. |
| DQ-001-04 | PLC functionality test. | PLC operates without errors. | PLC error logs. |
Detailed Test Cases
Test Case DQ-001-01
Objective: Verify inlet/exhaust temperature settings.
Procedure: Measure inlet and exhaust temperatures during operation.
Acceptance Criteria: Temperatures must be within specified limits.
Evidence: Calibration certificates and temperature logs.
Test Case DQ-001-02
Objective: Check spray rate functionality.
Procedure: Measure the spray rate during operation.
Acceptance Criteria: Spray rate must match defined specifications.
Evidence: Operational data logs.
Test Case DQ-001-03
Objective: Evaluate pan speed consistency.
Procedure: Monitor pan speed during operation.
Acceptance Criteria: Pan speed must remain stable.
Evidence: Speed measurement records.
Test Case DQ-001-04
Objective: PLC functionality test.
Procedure: Test PLC for errors during operation.
Acceptance Criteria: No errors should be logged.
Evidence: PLC error logs.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the validation team and Quality Assurance. A root cause analysis should be conducted to determine the impact on the validation process.
Approvals
Approved by: [Insert Name] – [Insert Title]
Date: [Insert Date]