Performance Qualification Protocol for Patch Compounding Vessel
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) is to verify that the Patch Compounding Vessel operates as intended and meets the specified acceptance criteria for the preparation of drug-polymer adhesive mixtures.
Scope
This protocol applies to the Patch Compounding Vessel (Jacketed SS) used in the production area for the preparation of transdermal patches. It covers the critical parameters that impact product quality and compliance.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Team: Responsible for providing necessary access and support during the PQ execution.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of trained personnel to conduct the PQ.
- Calibration of all measurement devices and instruments.
Equipment Description
The Patch Compounding Vessel (Jacketed SS) is designed for the preparation of drug-polymer adhesive mixtures. It features a jacket for temperature control, agitation capabilities, and is constructed from stainless steel to ensure product integrity.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-01 | Verify agitation speed and consistency | Agitation speed within defined limits | Calibration report, log of speeds |
| PQ-02 | Measure temperature during operation | Temperature maintained within specified range | Temperature logs |
| PQ-03 | Assess viscosity of mixture | Viscosity within specified limits | Viscosity test results |
| PQ-04 | Document mixing time | Mixing time within specified limits | Mixing time logs |
| PQ-05 | Review PLC audit trail for accuracy | No discrepancies found | PLC audit trail report |
Detailed Test Cases
Test Case PQ-01: Verify Agitation Speed and Consistency
Procedure: Set the vessel to the specified agitation speed. Monitor and record the speed over a defined period.
Acceptance: The agitation speed must remain within the defined limits as per the URS.
Test Case PQ-02: Measure Temperature During Operation
Procedure: Operate the vessel under normal conditions and record the temperature.
Acceptance: Temperature must remain within specified range.
Test Case PQ-03: Assess Viscosity of Mixture
Procedure: Take samples of the mixture at defined intervals and measure viscosity using a viscometer.
Acceptance: Viscosity must be within specified limits.
Test Case PQ-04: Document Mixing Time
Procedure: Start mixing the components and record the time taken to achieve the desired consistency.
Acceptance: Mixing time must be within specified limits.
Test Case PQ-05: Review PLC Audit Trail for Accuracy
Procedure: Access the PLC audit trail and verify all recorded parameters against expected values.
Acceptance: No discrepancies must be found in the audit trail.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan should be developed if necessary.
Approvals
Prepared By: ______________________ Date: ___________
Approved By: ______________________ Date: ___________