Document Control
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Reviewer Name]
Approval Date: [Insert Approval Date]
Performance Qualification Protocol for Sterile Holding Tank
Meta Description: This document outlines the Performance Qualification protocol for the Sterile Holding Tank used in the production of sterile powders and lyophilized products, ensuring compliance with URS Annex1 and Annex15.
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Sterile Holding Tank’s capability to maintain the required conditions for holding sterile filtered bulk, ensuring compliance with regulatory standards and specifications.
Scope
This protocol applies to the Sterile Holding Tank located in the Production area, specifically for the holding of sterile filtered bulk used in the manufacture of sterile powders and lyophilized products.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ documentation.
- Production Personnel: Responsible for operating the Sterile Holding Tank as per the validated procedures.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary documentation, including user requirements specification (URS) and equipment manuals.
- Training of personnel on the operation of the Sterile Holding Tank.
Equipment Description
The Sterile Holding Tank is a pressurized vessel designed to hold sterile filtered bulk under controlled conditions. It is equipped with pressure monitoring and vent integrity systems to ensure sterility and product quality.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Pressure hold integrity test | Pressure maintained within specified range for duration of test | PLC logs, pressure gauge readings |
| PQ-002 | Vent integrity verification | No contamination detected during vent checks | Vent integrity test results |
Detailed Test Cases
Test Case 1: Pressure Hold Integrity Test
Objective: To ensure the Sterile Holding Tank maintains the required pressure during operation.
Procedure: Initiate the pressure hold test and monitor the pressure readings for a specified duration.
Acceptance Criteria: Pressure must remain within the specified range as defined in the URS.
Evidence: Document PLC logs and pressure gauge readings.
Test Case 2: Vent Integrity Verification
Objective: To confirm that the vent system is functioning correctly and does not allow contamination.
Procedure: Conduct a vent integrity test using appropriate methods as defined in the operational procedures.
Acceptance Criteria: No contamination detected; results must meet the criteria outlined in URS Annex1 and Annex15.
Evidence: Record the results of the vent integrity tests.
Deviations
Any deviations from the established acceptance criteria must be documented, investigated, and resolved prior to approval of the PQ results. A deviation report must be generated and reviewed by Quality Assurance.
Approvals
Upon successful completion of the Performance Qualification tests and resolution of any deviations, the protocol will be reviewed and approved by the Quality Assurance team.