Document Control:
Document ID: PQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approved By: [Name]
Performance Qualification Protocol for Shaking Incubator in Biologics Upstream Processing
Objective: To validate the performance of the Shaking Incubator used for cell culture growth in the production area, ensuring compliance with established acceptance criteria.
Scope: This protocol applies to the Performance Qualification of the Shaking Incubator utilized in the production of biologics, specifically in upstream processing for cell culture growth.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Ensures compliance with regulatory standards and reviews documentation.
- Production Staff: Operates the equipment as per the validated procedures.
Prerequisites:
- Installation Qualification (IQ) must be completed and approved.
- Operational Qualification (OQ) must be completed and approved.
- All personnel involved must be trained on equipment operation and validation procedures.
Equipment Description:
The Shaking Incubator is designed for optimal cell culture growth, providing controlled temperature and agitation. It is equipped with a PLC for logging critical parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001-01 | Verify temperature uniformity across the incubator. | Temperature within ±2°C of set point. | Temperature logs from PLC. |
| PQ-001-02 | Verify RPM uniformity during operation. | RPM within ±5% of set point. | RPM logs from PLC. |
| PQ-001-03 | Review PLC logs for data integrity. | No data gaps or anomalies. | Log review report. |
Detailed Test Cases:
- Temperature Uniformity:
- Set the incubator to a specific temperature.
- Place temperature probes at various locations.
- Record temperatures after stabilization.
- RPM Uniformity:
- Set the incubator to a specific RPM.
- Measure RPM at multiple points.
- Document RPM readings.
- Data Integrity Check:
- Export PLC logs.
- Check for completeness and accuracy of data.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed as needed.
Approvals:
Prepared By: [Name] Date: YYYY-MM-DD
Reviewed By: [Name] Date: YYYY-MM-DD
Approved By: [Name] Date: YYYY-MM-DD