Standard Operating Procedure for Receipt, Handling, Qualification and Numbering of HPLC and UPLC Column

SOP for HPLC Column Qualification
SOP for HPLC Column Qualification and Management

Standard Operating Procedure for Receipt, Handling, Qualification and Numbering of HPLC and UPLC Column

1. Purpose:

To lay down a procedure for Receipt, Handling, Qualification and Numbering of HPLC and UPLC Column.

2. Scope:

The scope of this is applicable for Receipt, Handling, Qualification and Numbering of HPLC Column in quality control laboratory at [company name].

3. Responsibility:

Quality Control (QC) Person: To order required columns, to maintain the inventory, to qualify the column based on its performance and column numbering.

QC supervisor: To review the column qualification report.

QC Head: To approve the column qualification report and to ensure the compliance.

4. Definitions:

Not Applicable

5. Procedure:

5.1 Procedure for procurement and use of HPLC/ UPLC column

• When new product introduced, required new columns shall be procured. Whenever, column under use is not performing as intended, new columns shall be procured.

• Procurement of column shall be initiated by laboratory support function.

• Procurement of HPLC/ UPLC column shall be done in accordance with the requisition initiated by QC section head as per the requirement.

• On receipt of column, QC person shall check the certificate provided by column manufacturer against the respective requisition and applicable method of analysis. On satisfactory evaluation, QC person shall inward the column. In case of any discrepancy, column shall be returned back to procurement department to process return.

• QC person shall make necessary entries in the Column Receipt logbook and place the same in column cabinet and map the location in the logbook.

• The columns shall be stored and used as per the instructions provided by the column manufacturer.

• QC supervisor shall allocate the column to the analyst at the time of analysis. Analyst shall first qualify the column as per the column qualification procedure.

• The column qualification shall be done product and test specific.

• Preserve or store the column in the solvent(s) recommended by manufacturer or R&D. Use only HPLC grade solvents or solvents recommended in the method of analysis.

• To have a long life, always filtered and degassed mobile phase and well prepared and filter sample for analysis.

• Column received from R&D shall be qualified as per qualification procedure. Details of receipt of column shall be made in the logbook applicable for received columns from R&D.

• Whenever same column to be used for multiple material or product, it is required to be qualified for all the products or materials for which the column is applicable.

• The columns shall be labeled for respective product(s) or material(s) names for which it is to be used.

• In case of any product, there is uncertainty regarding repeated failure of system suitability, column performance shall be done before use as pre respective format. Material or product specific criteria shall be decided for the column prior to use.

• In case HPLC column is provided on temporary basis to other manufacturing locations or R&D center, it shall be documented in column usage logbook.

5.2 Handling precautions of HPLC/ UPLC columns

• Use Personal Protective Equipment (PPE) while performing the activity (E.g. laboratory coat, Goggles, Hand Gloves, Nose mask, etc.)

• HPLC columns shall be handled carefully to prevent any physical damaged and physical stress to prevent deterioration of column performance.

• Use safety precautions while discarding the columns.

• While usage of column for analysis, ensure that all the rinsing line, solvent line, washing line on the system are adequately immersed in the reservoir.

• As and when the analysis is carried out with higher column oven temperature, allow the column to cool down to laboratory temperature without stopping the flow after completion of analysis.

• While apply the flow rate, always flow rate at 0.1 ml/min and increase incrementally over the 5 minutes to get desired. While decreasing the flow rate reverse the same process, decrement the flow gradually.

• Flush the column for optimum time, avoid it for longer time to preserve the column performance and long life.

• Always store the column with recommended solvent(s), prevent it from dying. Always close the column ends using end caps. Ensure adequate closure.

• Buffer shall never be selected as solution to store the HPLC column.

5.3 Precautions while handling for HPLC/ UPLC columns

• Keep the HPLC column under lock and key.

• Prevent the columns from mechanical jerk.

• Use HPLC grade solvent(s) for chromatographic analysis. Use of impure solvents may cause irreversible adsorption of contaminants and impurities at the column head and over the stationary phase. It will block and reduce the adsorption/ active sites, reduce the selectivity of the column and lead to peak related issues such as peak splitting in the chromatogram.

• Use aqueous mobile phase freshly prepared to prevent potential of microbial growth, which could cause blockage of inline filters and columns.

• Set the column flow in the direction indicated by manufacturer.

5.4 Numbering of the Column:

• HPLC Column Number shall done follows:

HPC-AAAA

AAAA – Serial Number

5.5 Qualification of the HPLC/ UPLC Column:

• The column shall be qualified before use and consider for analysis.

• System Suitability shall be checked for the intended test applicable for the product or material for which the column to be used.

• System suitability criteria should be satisfactorily meet to consider the column as qualified for the use for routine analysis.

• Column qualification shall be documented in the Column Qualification record as per respective format.

• In case the column qualification does not meet the criteria, column shall be washed using a shipping solvent as per certificate of analysis supplied with column. Again attempt to perform the column qualification. If found non satisfactory, it shall be Rejected and necessary entries shall be made in the logbook.

• The rejected column shall be return back to the procurement department with details of procurement to process it further.

5.6 Cleaning and Storage of HPLC/ UPLC Column:

• The column shall be flushed with the eluent/ mobile phase for around 15 minutes and then stop the flow.

5.6.1 Solvent used for washing: Column washing shall be done using the solvent recommended by column manufacturer. If no specific instruction provided, it shall be washed using Water : Acetonitrile (90 : 10) shall be used for column washing.

5.6.2 Solvent used for storage:

• Solvent recommended by Manufacturer, if not recommended, Acetonitrile shall be used to store the column.

• Open the purging knob and purge the pump with washing solvent.

• Close the knob and flush the column using the washing Solvent for 45 – 60 minutes.

• Flush the column for around 15 minutes using the storage solvent.

• Stop the flow and remove the column.

• Close both the end of the column with end caps and store in designated place.

• If the column is not used for three months, flush for around 60 minutes with 1 mL flow rate using fresh 100 % solvent (Acetonitrile or Methanol) in order to prevent drying of stationary phase.

5.7 Procedure for discontinuation of column:

• In case the HPLC column used in routine analysis does not meet the system suitability criteria given for the particular test in the product, the column shall be rejected.

• Rejected column shall be destroyed. Record for destruction shall be maintained in respective logbook.

• HPLC calibration column shall be used for maximum 600 injections or 10 calibration sequences. Performance of column shall be monitored, based on performance also, it can be discontinued.

6. Frequency:

On receipt of new column and whenever required

7. Formats:

7.1 HPLC Column qualification protocol

7.2 HPLC Column inward register

7.3 HPLC Column discontinuation record

7.4 R&D Column inward register

7.5 Column location chart

7.1 HPLC/UPLC Column Qualification Protocol

HPLC Column Qualification Protocol

Column Type:   

Column Number:            

Receipt Date:                    

Qualification Date:          

Product:

Test:

Reference method of analysis No/ Rev. No..:

No. of Injections:

A. R. No. :

System Suitability:

System Suitability Parameters: 

Resolution: [Limit:                   ]: Observation [                            ]                                          

Theoretical Plates: [Limit:                   ]: Observation [                            ]                                                            

Tailing Factor:    [Limit:                   ]: Observation [                            ]                                  

% RSD: [Limit:                   ]: Observation [                            ]                                                   

Capacity Factor: [Limit:                   ]: Observation [                            ]                                 

Signal to Noise Ratio: [Limit:                   ]: Observation [                            ]                                       

Peak to Valley Ratio: [Limit:                   ]: Observation [                            ]                                        

Conclusion: The Column Qualifies / Does Not Qualify for the intended use.

Analyzed By / Date:                   

Checked By / Date:             

Approved By / Date: 

7.2 HPLC/UPLC column inward Register

Sr. No. 

Column Description:      

Received By/ Date:        

Issued By / Date:             

Column No.:      

Issued for Product/ Material:    

Received By/ Date:        

Checked By/ Date:

7.3 HPLC/UPLC Column discontinuation record

Column No.:                                      

Make:                                

Dimension:                        

Particle Size:

Sr. No.

Dedicated for:

Test:

Total No. of Injections:

Date of Issuance:

Date of Destruction:

System suitability parameter:    

Limit:    

Observation:                     

Remarks:  

Done by:

Checked by:

7.4 R&D/ Other location Column inward register

Sr. No. 

Receipt Date

Received from Location               

Product/ Material Name              

Column Description       

Column No.       

Received By/ Date          

Checked By/ Date

7.5 Column location chart

Location No.

Sr. No. 

Column No.       

Column Details

Product/ Material Name

Remarks

Prepared By      

Checked By

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