Document ID: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared by: [Insert Name]
Reviewed by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for Pouch Packaging & Seal Integrity Tester
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Pouch Packaging & Seal Integrity Tester to ensure its capability to pack and verify seals accurately and consistently, directly impacting product quality.
Scope
This protocol applies to the Pouch Packaging & Seal Integrity Tester located in the Packaging area used for NDDS – Transdermal Microneedles / Advanced Patches.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Equipment Owner: Responsible for maintaining the equipment in accordance with manufacturer specifications.
Prerequisites
- Equipment must be installed and operational.
- Personnel must be trained on the operation of the equipment.
- All necessary materials and supplies must be available.
Equipment Description
The Pouch Packaging & Seal Integrity Tester is designed for testing the integrity of seals on packaging. It utilizes controlled temperature, pressure, and dwell time to ensure seal quality. The equipment features an audit trail for leak sensitivity testing.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-001 | Perform seal integrity test under specified conditions. | Seal integrity meets acceptance criteria defined in URS Annex11. | Test report with audit trail. |
| TP-002 | Verify temperature and pressure settings. | Settings within specified limits. | Calibration certificates and log. |
| TP-003 | Conduct leak sensitivity audit. | Leak sensitivity within acceptable limits. | Audit report. |
Detailed Test Cases
Test Case: TP-001
Objective: To ensure the seal integrity meets the specified acceptance criteria.
Procedure: Conduct the seal integrity test following the manufacturer’s guidelines. Record all relevant data.
Acceptance Criteria: Seal integrity must meet the criteria defined in URS Annex11.
Evidence: Documented test report with an audit trail.
Test Case: TP-002
Objective: To verify that the temperature and pressure settings are accurate.
Procedure: Check and record the temperature and pressure settings against the calibration standards.
Acceptance Criteria: Settings must be within specified limits.
Evidence: Calibration certificates and logbook entries.
Test Case: TP-003
Objective: To conduct a leak sensitivity audit to confirm the equipment’s capability.
Procedure: Execute the leak sensitivity test as per the defined protocol.
Acceptance Criteria: Leak sensitivity must be within acceptable limits.
Evidence: Audit report detailing the results.
Deviations
Any deviations from the protocol must be documented and justified. Approval from Quality Assurance is required for any changes to the protocol or acceptance criteria.
Approvals
This protocol must be approved by the Quality Assurance department prior to execution.