Document Control
Document Number: DQ-SSM-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for the Suppository Stripping Machine
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the Suppository Stripping Machine is designed and installed in accordance with user requirements and regulatory standards, ensuring its capability to effectively remove suppositories from molds with a direct impact on product quality.
Scope
This protocol applies to the Design Qualification of the Suppository Stripping Machine used in the Production area for the manufacturing of suppositories and implants.
Responsibilities
The Validation Team is responsible for the execution of this protocol, while the Quality Assurance Team will oversee compliance and final approval.
Prerequisites
All operators must be trained in equipment operation and relevant SOPs. The equipment must be installed and operational prior to the initiation of this DQ protocol.
Equipment Description
The Suppository Stripping Machine is designed to efficiently remove suppositories from molds, ensuring minimal product damage and maintaining product integrity. The machine features stripping alignment reject logic and an audit trail for critical parameters.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-SSM-01 | Verify stripping alignment | Alignment within specified tolerance | Calibration records |
| DQ-SSM-02 | Audit trail verification | Audit trail logs complete | Log review report |
Detailed Test Cases
Test Case 1: Stripping Alignment Verification
Objective: To ensure the stripping alignment is within specified tolerances.
Procedure: Measure the alignment using calibrated tools and compare with the acceptance criteria.
Expected Result: The alignment should fall within the defined tolerance limits.
Test Case 2: Audit Trail Verification
Objective: To confirm that the audit trail for the stripping process is complete and accurate.
Procedure: Review the audit trail logs for completeness and accuracy against the defined requirements.
Expected Result: All entries should be present and correctly logged.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Appropriate corrective actions must be taken and recorded.
Approvals
This protocol must be approved by the Validation Manager and Quality Assurance Manager before execution.
Data Integrity Checks
1. Ensure that all data entries are time-stamped and user-identified in the audit trail.
2. Conduct periodic reviews of the audit trail to ensure no unauthorized changes.
3. Implement backup procedures for data storage to prevent loss of critical information.