- PURPOSE:
- To describe the Operational Qualification of Medicament Preparation Vessel, its accessories and to define the specification of the system in order to:
- ensure that the equipment meets the Operational/Design limits as per user requirements.
- ensure that the equipment shall be operationally qualified in accordance with current Good Manufacturing Practices.
- SCOPE:
- The scope of this document applies to the operational qualification of Medicament Preparation Vessel.
- RESPONSIBILITIES:
- It is the responsibility of the Manufacturer to perform all the tests with respect to Operational qualification and compiling data in co-ordination with client.
- It is the responsibility of the client to check and approve the Operational qualification.
- PROCEDURE:
- The following requirement / practices apply to Medicament Preparation Vessel Operational Qualification activities:
- To verify the components design parameters.
- Review the preventive maintenance procedures, cleaning procedures and general operational procedure to ensure that they are comprehensive for reliable performance of the equipment.
- OPERATIONAL QUALIFICATION TESTS:
The table below lists the tests to be performed as part of the Operational Qualification phase.
| TEST NUMBER | CRITICAL FEATURE |
| 5.1 | Working Capacity Verification |
- Working Capacity Verification
- Purpose – To verify that the Medicament Preparation Vessel work satisfactorily at its maximum capacity.
- Test equipment – None Required.
- Procedure:
- Fill a measured volume of potable water equivalent to 150 L in Medicament Preparation Vessel.
- Place the lid over the Vessel.
- Acceptance Criteria – The Medicament Preparation Vessel shall store the above mentioned volume of water.
- Working Capacity Verification Test Results
| Test | Results | Meets Test
(Yes / No) |
Test Done by | Date |
| Fill a measured volume of potable water equivalent to 150 L in Medicament Preparation Vessel | The Medicament Preparation Vessel shall store the mentioned volume of water |
- Conclusions / Comments:
- Operational Qualification Tests Status
- The table below lists the tests performed and related results.
| Test Number
|
Critical Feature
|
Pass / Fail | Deviation Found | ||
| Pass | Fail | Yes | No | ||
| 5.1 | Working Capacity Verification | ||||
- LIST OF STANDARD OPERATING PROCEDURES
| Sr. No. | Description | SOP No. | Verified By | Date |
| 1 | Operating Procedure of Medicament Preparation Vessel | |||
| 2 | Cleaning Procedure of Medicament Preparation Vessel | |||
| 3 | Preventive maintenance of Medicament Preparation Vessel |
- Data Analysis , Summary of OQ & Recommendations
- AMENDMENT RECORD
Sr. No. |
Item Name |
Remarks |
Signature & Date |
- Note: Any changes made in the system must be recorded in this sheet.
- CONCLUSION
