Document ID: DQ-CIP-001
Version: 1.0
Effective Date: YYYY-MM-DD
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Design Qualification Protocol for CIP Skid in IV Infusions
Objective: To validate the CIP Skid used for the automated cleaning of tanks and lines in the production of IV infusions, ensuring compliance with regulatory requirements and operational efficiency.
Scope: This protocol applies to the CIP Skid utilized in the cleaning of LVP/SVP production equipment, focusing on critical parameters that impact product quality.
Responsibilities:
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production: Ensure equipment is available and operational for testing.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) completed.
Equipment Description: The CIP Skid is designed for the automated cleaning of tanks and lines used in the production of IV infusions, ensuring sterile conditions and compliance with industry standards.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Flow Rate Verification | Flow rate within specified limits | Flow rate logs |
| DQ-002 | Temperature Check | Temperature within specified limits | Temperature logs |
| DQ-003 | Conductivity Test | Conductivity within specified limits | Conductivity logs |
| DQ-004 | Cycle Time Validation | Cycle time within specified limits | Cycle time logs |
| DQ-005 | Audit Trail Review | Complete and accurate audit trail | Audit trail report |
Detailed Test Cases:
- Flow Rate Verification: Measure the flow rate during the cleaning cycle and compare with defined specifications.
- Temperature Check: Monitor the temperature of the cleaning solution during the cleaning cycle.
- Conductivity Test: Assess the conductivity of the cleaning solution post-cleaning.
- Cycle Time Validation: Record and verify the total cycle time for the cleaning process.
- Audit Trail Review: Ensure all actions are logged and can be traced back for compliance.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality.
Approvals:
____________________ Prepared by
____________________ Approved by