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Operational Qualification of HPLC (High Performance Liquid Chromatography)

In this post we learn Operational Qualification of HPLC (High Performance Liquid Chromatography) in Pharmaceuticals Quality Control Laboratory.

1.0 OBJECTIVE

To assure that the equipment used for analysis, is operated, and qualified according to the specifications mentioned in the equipment catalog and complies with company and regulatory standards and guidance Operational Qualification of HPLC (High Performance Liquid Chromatography).

2.0 SCOPE:

This protocol applies only to “High-Performance Liquid Chromatograph 1260 series” for its Operational qualification.

Qualification of support utilities is not within the scope of this qualification protocol.

3.0 REFERENCES

  • Validation manual/ Validation Master Plan
  • SOP for QA/ QC Equipment Validation
  • Operator’s Manual

4.0 EQUIPMENT/ SYSTEM DESCRIPTION:

EQUIPMENT NAME:          High Performance Liquid Chromatograph

MODEL:                               LC10AS

MANUFACTURER:              Schemadzu

VENDER:                              Pharmation

DESCRIPTION:                    This is a High Performance Liquid Chromatograph, which is fully equipped instrument i.e. with,

  • UV/ VIS variable wavelength Detector
  • Manual injector and
  • Isocratic HPLC Pump.

UTILITIES:                           Following utilities are required to install this equipment.

  • Power supply (E&M Department)
  • Printer for the computer (IT Department)

SOFTWARE:

5.0 QUALIFICATION TEST PROCEDURES

I) UV/ VIS Variable Wavelength Detector:           

Objective:

The objective of this test is to verify and document that the critical instruments used to monitor or control the system are operated and tested in accordance with available specification documentation.

Validation Test Evaluation:

 
S.NO.   TESTS PERFORMED SPECIFICATION RESULTS STATUS VERIFIED BY
1   VWD Intensity Spectrum Passed Passed OK
2   VWD Holmium Spectrum Passed Passed OK
3   Calibration Test Passed Passed OK
4   VWD Cell Test Passed Passed OK
5   VWD Dark Current Test Passed Passed OK

Acceptance Criteria Met?

 

YES: __________________              NO:  ___________________

 

INITIALS: _______________           DATE:  _________________

 

If “NO”, Explain in Comment

COMMENTS:

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

HPLC Quaternary Pump

Objective:

The objective of this test is to verify and document that the critical instruments used to monitor or control the system are operated and tested in accordance with available specification documentation.

ii) HPLC Quaternary Pump

Objective:

The objective of this test is to verify and document that the critical instruments used to monitor or control the system are operated and tested in accordance with available specification documentation.

HPLC Pump:

 
S.NO. TESTS PERFORMED SPECIFICATION RESULTS STATUS VERIFIED BY
1 Solvent Flow 10 ml/ min 10.0ml/ min OK
2 Pressure Passed Passed OK
3 Leak Test Passed Passed OK

 

Acceptance Criteria Met?

YES: __________________              NO:  ___________________

 

INITIALS: _______________           DATE:  _________________

 

If “NO”, Explain in Comment

COMMENTS:

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

iii) Software Response

Objective:

The objective of this test is to verify and document that the critical instruments used to monitor or control the system are operated and tested in accordance with available specification documentation.

Software:

 
S.NO. TESTS PERFORMED SPECIFICATION RESULTS STATUS VERIFIED BY
1 Response to HPLC Pump Responded Responded OK
2 Response to HPLC Detector Responded Responded OK

Acceptance Criteria Met?

YES: __________________              NO:  ___________________

INITIALS: _______________           DATE:  _________________

If “NO”, Explain in Comment

COMMENTS:

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

 

6.0 Appendices

Appendix A –  Qualification Notes

Appendix B –  Qualification Test Equipment Calibration Certificats

Appendix C –  Deviations

Appendix D –  Test Data Documentation

 

 

Appendix A   

Qualification Notes

(Executed)

Prepared By: ____________________________                            Date:_____________

Reviewed By: _____________________________                          Date:_____________

 

Appendix B 

Qualification Test Equipment Calibration Certificates

Instrument Instrument No. 01 Instrument No. 02 Instrument No. 03
Description HPLC Detector HPLC Pump
Manufacturer
Model No.
Serial No.
Protocol test No.
Instrument Used For
Calibration No.
Calibration Date
Calibration due Date
Verified By/ Date

COMMENTS

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

Appendix C 

  Deviations LISTING

(Executed)

Deviation no. Deviation description Deviation Page No. Addendum No.

(if applicable)

 

QUALIFICATION PROTOCOL DEVIATION FORM

Deviation No. : Test No. : Page No. :
Deviation Description

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

 

Corrective Action Response

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

Prepared By :  ______________________________________    _________________

Date

Approved By : _____________________________________      __________________

Date

Corrective Action Response

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

 

Prepared By :  ______________________________________    _________________

Date

Approved By : _____________________________________      __________________

Date

QUALIFICATION PROTOCOL DEVIATION FORM

Addendum No. : Test No. : Page No. :
Modification Description/ Comments :

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

Completed By :  ______________________________________    _________________

                                                                                               Date

Approved By :  ______________________________________    _________________

                                                                                                Date

Appendix D 

Test Data Documentation

(Executed)

 Item

 No.

Title/ Description Document

ID No.

Document Date Rev. No. Location Verified By/ Date
1   VWD Intensity Spectrum
2   VWD Holmium Spectrum
3   Calibration Test
4   VWD Cell Test
5   VWD Dark Current Test
6
7
8
9

COMMENTS

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

____________________________________________________________________

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