Operational Qualification Protocol for Capsule/Blister Filler in Inhaled NDDS Powders
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Objective: To validate the operational qualification of the Capsule/Blister Filler used in the production of inhalation powder dose units, ensuring compliance with URS Annex 11.
Scope: This protocol applies to the Capsule/Blister Filler used for filling inhalation powder dose units in the Production area. It encompasses the verification of key critical parameters.
Responsibilities:
- Validation Team: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Team: Provide access to equipment and assist during testing.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Availability of all necessary documentation, including User Requirements Specification (URS).
- Training of personnel on equipment operation.
Equipment Description:
The Capsule/Blister Filler is designed for the precise filling of inhalation powder dose units, ensuring fill weight uniformity and compliance with regulatory standards. It features a reject logic audit trail for critical parameters.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify fill weight uniformity | Fill weight within ±5% of target | Weight logs |
| OQ-02 | Audit reject logic functionality | All rejects logged with timestamp | Audit trail report |
Detailed Test Cases:
- Test Case OQ-01:
Procedure: Fill 10 capsules and record weights. Repeat for 3 batches.
Acceptance: All weights must be within ±5% of the target fill weight.
Evidence: Record of weights for each batch.
- Test Case OQ-02:
Procedure: Simulate reject conditions and verify audit trail.
Acceptance: All rejects must be logged with a timestamp.
Evidence: Printout of audit trail report.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A corrective action plan must be established.
Approvals:
- Validation Team Lead: ______________________ Date: ___________
- Quality Assurance: ______________________ Date: ___________
- Production Manager: ______________________ Date: ___________
Data Integrity Checks: Ensure that all data entries are time-stamped and logged, with regular audits of electronic records to confirm compliance with data integrity standards.