Document Number: DQ-TP-001
Version: 1.0
Effective Date: 2023-10-01
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Bilayer/Multilayer Tablet Press
Meta Description: This document outlines the Design Qualification protocol for a bilayer/multilayer tablet press, focusing on critical parameters and compliance for solid dosage forms.
Objective: To ensure that the bilayer/multilayer tablet press meets the specified requirements for the production of multilayer tablets, ensuring quality and compliance with regulatory standards.
Scope: This protocol applies to the validation of the bilayer/multilayer tablet press used in the production area for solid dosage forms, focusing on direct product impact and criticality.
Responsibilities:
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production: Provide necessary equipment and operational support.
Prerequisites:
- Completion of User Requirement Specification (URS) as per Annex 11.
- Installation Qualification (IQ) completed and approved.
Equipment Description: The bilayer/multilayer tablet press is designed for producing multilayer tablets with precise layer weight control and force profile PLC capabilities. The equipment is critical for ensuring the quality of the final product.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-TP-01 | Verify layer weight control settings | Settings match URS specifications | Calibration records |
| DQ-TP-02 | Test force profile PLC during operation | Force profile within specified limits | Force profile graphs |
Detailed Test Cases:
- Test ID: DQ-TP-01
- Procedure: Verify layer weight control settings against the URS.
- Acceptance Criteria: Settings must match documented specifications.
- Evidence: Calibration records and screenshots of settings.
- Test ID: DQ-TP-02
- Procedure: Operate the tablet press and monitor the force profile PLC.
- Acceptance Criteria: Force profile should remain within defined operational limits.
- Evidence: Force profile graphs and operational logs.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be established for any critical deviations.
Approvals:
- Prepared by: [Your Name] – [Date]
- Reviewed by: [Reviewer Name] – [Date]
- Approved by: [Approver Name] – [Date]
Data Integrity Checks:
- Ensure all data entries are timestamped and user-identified.
- Implement audit trails for critical parameters.
- Regular backups of data logs and reports.