LAB EQUIPMENT H.P.L.C

STANDARD OPERATING PROCEDURE

SUBJECT :                     LAB EQUIPMENT  H.P.L.C

DEPARTMENT           : QA SOP NO.                      :xxxx Page No                       : 1 of  3 Effective Date             : XXXX Next Review                : XXXX SOP REVISION           : XX

1.0       OBJECTIVE:

To provide guidelines for Operation & Maintenance of HPLC System.

2.0       POLICY: 

To ensure establish a procedure for operation of HPLC

3.0       PROCEDURE:

3.1       Switch on the Power supply and UPS.

3.2       Switch on the Pump, Detector, computer and Printer, allow to warm the system.       

3.3       Check the Column fitted on the system is suitable or not, if not install the required Column.

3.4       Wash the Column with washing solution (methanol & water each) for 30 minutes.

3.5       Prepare the Mobile phase and degas carefully.

3.6       Run the Mobile phase at required flow rate to saturate the Column and check the baseline.

3.7       Set the required detector parameters on Detector.

3.8       If the base line is o.k. Then set the required chromatogram parameters on Method file or run the injections on default method first and set suitable parameters.

3.9       Prepare the standard solutions and run five standard injections on the system and check system suitability. The injecting sample does not have any air bubbles prior to injection.

3.10     If the RSD of the Standards chromatograms is less than two, then the system is suitable for Sample injections. Otherwise repeat the Standard injections till you get the RSD below two.

3.11     Inject the required Sample and take the chromatograms and calculate the Percentage of Active ingredient on the basis of respective peak areas.

PRIME MOVER                                CONCURRER                                                  APPROVER EXECUTIVE (Q.A)                    PRODUCTION MANAGER                                     G.M (Q.A)

                       

                        SOP No.     : xxx

                        Page            : 2 of 3

                                                                                                                        Revision No:xx

3.12     After completion of work, the Column must be washed with wash solution for one hour.

3.13     For better performance of HPLC system adhere to the following guidelines:

3.13.1  Use only HPLC grade chemicals.

3.13.2  Mobile phase and all solutions of HPLC must be filtered and degassed.

3.13.3  Filter the standard and sample solutions using 0.45 micron nylon 66 membrane filter.

3.13.4  Do not operate the system above 3000psi.

User levels :

●  Admin has the authority to access the process of programming, new method creation, modifications

     and Audit trails.

●  While the users accessibility is restricted to running and viewing  and printing of reports for the

     purpose of analysis.

4.0       FREQUENCY:  As and when required.

5.0       RESPONSIBILITY:  Executive Q.A.

6.0       REVIEW GUIDE: Log register & Calibration register.

7.0       ANNEXURE: -------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	X
Warehouse	x	X
General	x	X
Maintenance	x	X

PRIME MOVER                                CONCURRER                                                  APPROVER EXECUTIVE (Q.A)                    PRODUCTION MANAGER                                     G.M (Q.A)

                         SOP No.       : xxxx

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                                                                                                                        Revision No :xx

9.0       REVISION HISTROY           :

Revision number	Change
Revision no 06 to 07	1. SOP format revised.
Revision no 07 to 08	1. SOP revised as per due date.
Revision no 08 to 09	1. SOP revised as per due date. 2. Name of Prime Mover, Concurrer & Approver included in the       SOP. 3. SOP Revision No. included in all the annexures of SOP. 4. Annexure subheading and details of annexures included in SOP.
Revision no 09 to 10	1.SOP revised to include user levels in the SOP.

PRIME MOVER                                CONCURRER                                                  APPROVER EXECUTIVE (Q.A)                    PRODUCTION MANAGER                                     G.M (Q.A)