Operational Qualification Protocol for Suppository Stripping Machine
Document Number: OQ-SS-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Your Name]
Approved By: [Approver’s Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Suppository Stripping Machine operates according to its intended use and meets the specified acceptance criteria as outlined in the User Requirement Specification (URS) Annex 11.
Scope
This protocol applies to the Suppository Stripping Machine used in the Production area for the removal of suppositories from molds. It covers the qualification activities necessary to establish that the equipment is functioning as intended.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the OQ protocol and results.
- Production Personnel: Responsible for assisting in the execution of the protocol and providing necessary documentation.
Prerequisites
- Installation Qualification (IQ) must be completed and approved.
- Training on the operation of the Suppository Stripping Machine must be completed.
- All necessary materials and equipment must be available.
Equipment Description
The Suppository Stripping Machine is designed to efficiently remove suppositories from their molds while ensuring product integrity. Key features include an automated stripping mechanism, adjustable alignment settings, and a reject logic system for identifying misaligned products.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| OQ-01 | Verify stripping alignment settings. | Alignment settings must be within specified range. | Calibration records. |
| OQ-02 | Test reject logic audit trail. | Audit trail must accurately reflect all rejects. | Audit trail report. |
Detailed Test Cases
Test Case OQ-01: Verify Stripping Alignment Settings
Objective: Ensure that the stripping alignment settings are correctly configured.
Procedure: Adjust the alignment settings and perform a test run. Measure the alignment of the first 10 suppositories removed.
Acceptance Criteria: All suppositories must be stripped without misalignment.
Evidence: Document alignment measurements and photographic evidence of the stripping process.
Test Case OQ-02: Test Reject Logic Audit Trail
Objective: Confirm the functionality of the reject logic and the accuracy of the audit trail.
Procedure: Simulate misaligned suppositories and document the system’s response. Review the audit trail for accuracy.
Acceptance Criteria: The audit trail must reflect all instances of rejects during the test run.
Evidence: Printout of the audit trail and a summary of the test run.
Deviations
Any deviations from the protocol must be documented and approved by the Quality Assurance department. A root cause analysis must be conducted for any critical deviations.
Approvals
Prepared By: [Your Name] – [Date]
Approved By: [Approver’s Name] – [Date]