Design Qualification Protocol for Automatic Capsule Filling Machine
Document Control:
- Document Number: DQ-OSD-CFM-001
- Revision Number: 01
- Effective Date: [Insert Date]
- Prepared By: [Insert Name]
- Reviewed By: [Insert Name]
- Approved By: [Insert Name]
Objective
The purpose of this Design Qualification (DQ) Protocol is to ensure that the Automatic Capsule Filling Machine meets the specified requirements and is suitable for its intended use in the production of solid dosage forms.
Scope
This protocol applies to the design qualification of the Automatic Capsule Filling Machine used in the production area for capsule filling processes. It covers equipment validation activities and ensures compliance with applicable regulations.
Responsibilities
The following personnel are responsible for the execution and approval of this DQ protocol:
- Validation Team: Responsible for conducting the qualification activities.
- Quality Assurance: Responsible for reviewing and approving the protocol.
- Production Manager: Ensures that the equipment is operated according to the specifications.
Prerequisites
Prior to executing this DQ protocol, the following prerequisites must be met:
- Installation Qualification (IQ) must be completed and approved.
- Operating procedures must be established and available.
- Staff training on the equipment must be completed.
Equipment Description
The Automatic Capsule Filling Machine is designed for efficient and accurate filling of capsules with powdered formulations. The machine operates under controlled conditions to ensure high fill weight accuracy and minimal rejects.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify fill weight accuracy | Fill weight within ±5% of target | Weighing logs |
| DQ-02 | Measure fill speed | Fill speed compliant with URS | Speed measurement logs |
| DQ-03 | Check reject rate | Rejects < 2% | Reject logs |
| DQ-04 | PLC functionality test | PLC operates without errors | PLC test logs |
Detailed Test Cases
Test Case DQ-01: Verify Fill Weight Accuracy
Objective: Ensure that the fill weight is within acceptable limits.
Procedure: Conduct fill weight measurements on a sample of filled capsules.
Acceptance Criteria: Fill weight must be within ±5% of the target weight.
Evidence: Documented fill weight measurements.
Test Case DQ-02: Measure Fill Speed
Objective: Confirm that the fill speed meets the specified requirements.
Procedure: Measure the time taken to fill a defined number of capsules.
Acceptance Criteria: Fill speed must comply with the URS.
Evidence: Documented speed measurements.
Test Case DQ-03: Check Reject Rate
Objective: Ensure that the reject rate is within acceptable limits.
Procedure: Review the reject rates from production logs.
Acceptance Criteria: Rejects must be less than 2%.
Evidence: Documented reject rates.
Test Case DQ-04: PLC Functionality Test
Objective: Verify that the PLC operates correctly during production.
Procedure: Monitor PLC operations during a production run.
Acceptance Criteria: PLC must operate without errors.
Evidence: Documented PLC operation logs.
Deviations
In the event of deviations from the acceptance criteria, a deviation report must be generated and approved by the Quality Assurance team. All deviations must be investigated and corrective actions implemented.
Approvals
This protocol must be signed and approved by the following personnel:
- Prepared By: _______________________ Date: ___________
- Reviewed By: _______________________ Date: ___________
- Approved By: _______________________ Date: ___________
Data Integrity Checks
As CSV is required, the following data integrity checks will be implemented:
- Audit trails for all data entries and modifications.
- Regular backups of all data collected during the qualification process.
- Access controls to ensure only authorized personnel can modify data.