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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