Performance Qualification Protocol for Fluid Bed Processor in Granulation
Document Number: PQ-FBP-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Fluid Bed Processor (FBP) for top spray granulation in the production of solid dosage forms.
Scope
This protocol applies to the Fluid Bed Processor used in the granulation process within the production area. It covers the qualification of the equipment to ensure it operates according to defined specifications and meets the acceptance criteria outlined in the URS Annex11.
Responsibilities
The Validation Team is responsible for the execution and documentation of the PQ protocol. The Quality Assurance (QA) department will review and approve the protocol and its results.
Prerequisites
Prior to executing this PQ protocol, the following must be completed:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
Equipment Description
The Fluid Bed Processor (FBP) is designed for top spray granulation of solid dosage forms. It operates under controlled conditions to ensure uniform granule size and moisture content.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-001 | Verify inlet temperature | Inlet temperature within specified range | Temperature logs |
| TP-002 | Verify outlet temperature | Outlet temperature within specified range | Temperature logs |
| TP-003 | Verify airflow rate | Airflow rate meets specifications | Airflow measurement records |
| TP-004 | Verify spray rate | Spray rate within defined limits | Spray rate records |
| TP-005 | Verify PLC functionality | PLC operates correctly | PLC test results |
Detailed Test Cases
Test Case: TP-001 – Inlet Temperature Verification
Procedure: Measure the inlet temperature during operation. Compare with the specified range.
Acceptance Criteria: Inlet temperature must be within the specified range.
Evidence: Document the temperature readings and confirm compliance.
Test Case: TP-002 – Outlet Temperature Verification
Procedure: Measure the outlet temperature during operation. Compare with the specified range.
Acceptance Criteria: Outlet temperature must be within the specified range.
Evidence: Document the temperature readings and confirm compliance.
Test Case: TP-003 – Airflow Rate Verification
Procedure: Measure the airflow rate during operation. Verify against specifications.
Acceptance Criteria: Airflow rate must meet specifications.
Evidence: Document airflow measurements and confirm compliance.
Test Case: TP-004 – Spray Rate Verification
Procedure: Measure the spray rate during operation. Compare to defined limits.
Acceptance Criteria: Spray rate must be within defined limits.
Evidence: Document spray rate measurements and confirm compliance.
Test Case: TP-005 – PLC Functionality Verification
Procedure: Test all PLC functions during operation.
Acceptance Criteria: PLC must operate correctly without errors.
Evidence: Document PLC test results and confirm compliance.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed. A root cause analysis should be performed, and corrective actions must be implemented as necessary.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]