Document Control:
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Design Qualification Protocol for Ophthalmic Ointment Manufacturing Vessel
Objective: The objective of this Design Qualification (DQ) protocol is to ensure that the Ophthalmic Ointment Manufacturing Vessel meets the specified requirements for the production of sterile and non-sterile ointment bases, ensuring product quality and compliance with regulatory standards.
Scope: This protocol applies to the qualification of the Ophthalmic Ointment Manufacturing Vessel used in the production area for the preparation of sterile and non-sterile ointments. The document covers the critical parameters, acceptance criteria, and responsibilities involved in the DQ process.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for operating the equipment as per the validated procedures.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the equipment.
- Training of personnel on the equipment operation and safety procedures.
Equipment Description: The Ophthalmic Ointment Manufacturing Vessel is a Sigma/Planetary/Vacuum type equipment designed for the preparation of sterile and non-sterile ointment bases. The equipment features vacuum mixing capabilities and is equipped with PLC for monitoring critical parameters such as temperature, mixing speed, and torque.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify temperature control functionality. | Temperature maintained within ±2°C of set point. | Temperature logs from PLC. |
| T2 | Check vacuum operation. | Vacuum level reaches specified target within 5 minutes. | Vacuum gauge readings. |
| T3 | Assess mixing speed and torque. | Mixing speed within ±10% of set point; torque within specified range. | Torque and speed logs from PLC. |
Detailed Test Cases:
- Test Case T1: Set the temperature to 50°C and monitor for stability over a 30-minute period. Document any fluctuations.
- Test Case T2: Initiate vacuum and measure the time taken to reach the target vacuum level. Document the time and any discrepancies.
- Test Case T3: Set mixing speed to 100 RPM and measure the torque. Record the values and compare with the acceptance criteria.
Deviations: Any deviations from the acceptance criteria must be documented in the deviation log, including the reason for the deviation and the corrective actions taken.
Approvals:
- Prepared by: ___________________ (Name, Title, Date)
- Reviewed by: ___________________ (Name, Title, Date)
- Approved by: ___________________ (Name, Title, Date)
Data Integrity Checks:
- Ensure all PLC logs are securely stored and backed up.
- Regular audits of data entries to verify accuracy.
- Access control measures to prevent unauthorized changes to critical data.