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Operational Qualification of Medicament Preparation Vessel

  • 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

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