SOP for HPLC Column

1.0  Objective:

             To describe the procedure for receipt, validation, utilization and destruction of HPLC Column

2.0    Scope:

This SOP covers operating Procedure for receipt, validation utilization and destruction of      HPLC  column 

3.0       Responsibility:

           Junior Research Officer, Research Officer :Responsible for validation utilization and destruction of HPLC column as  per procedure.

           QA Officer/QA Manager: Review the records and governing
the document 

4.0       Procedure:

4.1  Columns are ordered as per the requirements of Finished Product Specification, Raw material specifications or any Pharmacopoeia.

4.2 After receiving the columns from purchase department, they are to be verified against the purchase request for suitability i.e. with respect to dimensions, particle size and stationary phase. If they do not match they shall be rejected and returned to supplier & intimate to store department.

4.3  At the time of the column performance check (CPC) make the entry in the column inward register  as per Annexure – I.

4.4 Mention a unique number to each Column. The column numbering system as follows:- Column Numbering System: e.g. - EQU/INS/001

  

4.5 For CPC of HPLC column perform the procedure as per described in manufacturer Certificate and prepare the Standard solution of available chemicals. Inject one injection of standard solution for evaluation.

4.6   Column shall be validated for theoretical plates which should be minimum 80% of any one Standard claimed by manufacturer.

4.7 On successful completion of the CPC record the value in Annexure II and the column shall be issued for regular routine testing.

4.8 Column utilisation is monitored by recording Number of Injections in Log book for column utilisation as per Annexure III.

4.9    During the uses of HPLC column, reject the column 

*          System suitability requirement of the product under
analysis are not met.

*          Broadening of the peak observed.

*          Splitting even after frit cleaning and washing.

4.10    Bent the rejected column  to avoid its further use.

5.0      Documentation:

5.1  Annexure 1- HPLC Column Inward Register  XXX/FRM/000

5.2   Annexure 2- Column Performance  Check      XXX/FRM/000

5.4  Annexure 3 - Log book for Column Utilisation XXX/FRM/000

6.0       History of  Revision:

Revision No.	Effective Date	Revision details	Reason for revision

ANNEXURE – 1

HPLC Column Inward Register

Sr. No. Date of validation Name of Column Dimension Lot No. / B. No. Make Identification Number Sign

SOP No.:XXX/SOP/000                 Format No.: XXX/FRM/000-00 

ANNEXURE – 2

Column Performance Check

Identification Number:

Name of Column:

Dimension:

Lot No. / B. No.:

Make:

Chromatographic Conditions:

Mobile Phase:

Diluents:

Flow rate:

Column Temp (if any):

Wavelength:

No. of Injections :

Injection Volume :

Standard Preparation:

Record the observations in the table below:

Parameter	Observed Results	Limit (NLT 80 % of Claim)	Remark (Accepted/ Not accepted)
Theoretical Plates

Remarks:

                                               

 SOP No.:XXX/SOP/000                                                                Format No.: XXX/FRM/000-00       

ANNEXURE – 3

Log book for Column Utilisation

Column Name                        : Column ID                   :
Sr. No.	Date of Use	Product Name	No. of Injection	Cumulative  No. of Injection	Analyst By	Remarks

SOP No.:XXX/SOP/000                                                                 Format No.: XXX/FRM/000-00