Performance Qualification Protocol for Automatic Capsule Filling Machine
Document Number: PQ-OSD-001
Version: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Automatic Capsule Filling Machine operates consistently and reliably within established parameters to ensure compliance with specified requirements.
Scope
This protocol applies to the Performance Qualification of the Automatic Capsule Filling Machine used in the production area for filling capsules. It addresses critical parameters that directly impact product quality and compliance.
Responsibilities
- Validation Team: Responsible for the execution and documentation of the PQ protocol.
- Quality Assurance: Responsible for reviewing and approving the PQ documentation.
- Production Team: Responsible for providing necessary support during the qualification process.
Prerequisites
- Installation Qualification (IQ) and Operational Qualification (OQ) must be completed and approved.
- All personnel involved must be trained on the equipment and procedures.
Equipment Description
The Automatic Capsule Filling Machine is designed for high-speed filling of capsules with powder or granules. It includes features for monitoring fill weight, speed, reject rates, and is controlled by a PLC system.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| TP-01 | Measure fill weight using calibrated scales. | Fill weight must be within +/- 5% of target. | Fill weight logs and calibration certificates. |
| TP-02 | Monitor filling speed during operation. | Filling speed must not exceed 100 capsules/min. | Speed logs and machine settings. |
| TP-03 | Log reject rates during production runs. | Reject rate must be less than 2%. | Reject logs and production reports. |
| TP-04 | Verify PLC functionality and data logging. | PLC must record all critical parameters accurately. | PLC logs and validation reports. |
Detailed Test Cases
Test Case TP-01: Fill Weight Measurement
Procedure: Conduct fill weight measurements on 10 randomly selected capsules. Record the weight of each capsule.
Acceptance Criteria: All measurements must be within +/- 5% of the target fill weight.
Test Case TP-02: Filling Speed Monitoring
Procedure: Operate the machine at the maximum speed and record the number of capsules filled in one minute.
Acceptance Criteria: The number of capsules filled must not exceed 100 capsules/min.
Test Case TP-03: Reject Rate Logging
Procedure: During a production run, track the number of capsules rejected and log the reasons.
Acceptance Criteria: The total reject rate must be less than 2% of the total production.
Test Case TP-04: PLC Functionality Verification
Procedure: Review PLC logs to ensure all critical parameters are logged accurately during operation.
Acceptance Criteria: All logged data must match the operational parameters.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed for impact on product quality. A root cause analysis will be conducted for any significant deviations.
Approvals
Prepared by: ___________________ Date: ___________
Reviewed by: ___________________ Date: ___________
Approved by: ___________________ Date: ___________
Data Integrity Checks
- Ensure that all data entries in the PLC system are timestamped and user-identified.
- Regular audits of data logs to verify accuracy and completeness.
- Implement electronic signatures for data approval processes.