Follow
1.0 OBJECTIVE : To set up a procedure for the operation and calibration of SHIMADZU HPLC Systems.
2.0 SCOPE : This procedure is applicable for the operation and calibration of SHIMADZU HPLC Systems (Prominence with PDA Detector, Prominence with UV Detector and 20ACHT series) in Quality Control Department of (Company Name).
3.0 RESPONSIBILITY
3.1 Operating personnel is responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his/ her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Make sure that the individual component (e.g. pump, detector etc) of the system, PC and the printer are connected to power supply.
5.2 Make sure that the LAN connection is OK.
5.3 Make sure that the solvent filter/diffuser is completely immersed in solvent.
5.4 Clean the solvent diffuser/filter once in a week.
5.5 Prime the system with fresh eluent (filtered and degassed).
6.0 PROCEDURE
6.1 Operation
6.1.1 All the HPLC systems in the QC are to be run by waters Empower 2 software.
6.1.2 Operation of SHIMADZU HPLC systems are to be performed according the sop No. QC190 (Operation and control of Empower 2 Software).
6.2 Qualification
6.2.1 The Qualification should be done according to the latest version of the approved protocols of SHIMADZU Corporation. Prior to operational qualification and performance qualification, preventive maintenance shall be done
6.2.2 The qualification activities shall be done by the certified engineer of the equipment supplier.
6.2.3 After completion of qualification activities the supplier engineer will fill up the report and sign. The filled and signed report will be reviewed critically by the responsible QC officer. Finally the qualification document will be approved by QC manager or his/her designee.
6.2.4 In case of a failure during qualification of equipment, the cause of the failure has to be identified and rectified which may involve replacement of some parts of the equipment. Then the qualification procedure has to be followed again.
6.2.5 Whenever a major part of equipment needs to be changed, it has to be gone through a change control procedure followed by performance qualification.
6.2.6 Acceptance criteria: The acceptance criteria should be mentioned in the respective approved protocol of SHIMADZU Corporation.
6.2.7 Frequency: One in 6 Months (+ 10 days).
6.2.8 Fill up the HPLC Log book as per the Form No.: FQC/097, HPLC Column usage log card as per the Form No.: FQC/086 and system suitability failure record as per the Form No.: FQC/150.
