Document Control
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Aseptic Filling Equipment in Long-Acting Injectables
Objective: To ensure that the Aseptic Filling equipment for Long-Acting Injectables meets all necessary design specifications and regulatory requirements.
Scope: This protocol applies to the Aseptic Filling equipment used for the aseptic filling of depot suspensions in production areas.
Responsibilities:
- Validation Team: Responsible for executing and documenting the qualification activities.
- Quality Assurance: Responsible for reviewing and approving the qualification documentation.
- Production Team: Responsible for providing input on operational requirements and participating in testing.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) must be completed prior to this protocol.
- Training of personnel on equipment operation and validation procedures.
Equipment Description:
The Aseptic Filling equipment is designed for the aseptic filling of Long-Acting Injectables (Depot Suspensions) into pre-filled syringes (PFS) and vials. The equipment includes features for maintaining sterility, ensuring accurate fill volumes, and providing a robust audit trail for compliance with regulatory standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify fill accuracy by assessing fill volumes of PFS and vials. | Fill volume must be within ± 5% of target volume. | Fill volume measurement logs. |
| T2 | Assess suspension homogeneity through visual inspection and sampling. | No visible particulates; homogenous suspension. | Visual inspection records and sample analysis reports. |
| T3 | Validate aseptic controls by testing environmental monitoring data. | All microbial counts must be below action limits as per Annex 1. | Environmental monitoring reports. |
| T4 | Review audit trail functionality of the filling equipment. | Audit trail must be complete with no gaps or unauthorized changes. | Audit trail logs. |
Detailed Test Cases:
Test Case T1: Verify fill accuracy.
- Procedure: Collect samples from filled PFS and vials, measure fill volumes.
- Acceptance Criteria: Fill volume must be within ± 5% of target volume.
- Evidence: Documented measurement logs.
Test Case T2: Assess suspension homogeneity.
- Procedure: Visually inspect and sample filled products for homogeneity.
- Acceptance Criteria: No visible particulates; homogenous suspension.
- Evidence: Inspection records and analysis reports.
Test Case T3: Validate aseptic controls.
- Procedure: Review environmental monitoring data for the filling area.
- Acceptance Criteria: All microbial counts must be below action limits as per Annex 1.
- Evidence: Environmental monitoring reports.
Test Case T4: Review audit trail functionality.
- Procedure: Examine audit trail logs for completeness and accuracy.
- Acceptance Criteria: Audit trail must be complete with no gaps or unauthorized changes.
- Evidence: Audit trail logs.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A formal deviation report should be generated and approved by Quality Assurance.
Approvals:
- Prepared By: ______________________ Date: ___________
- Reviewed By: ______________________ Date: ___________
- Approved By: ______________________ Date: ___________