Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns

1. Objective

To lay down the procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns.

• Scope

This SOP is applicable for all the GC columns used in Quality Control Laboratory. 

• Responsibility

QC Chemist/Officer QC-Officer/ QC-Executive     : To follow the procedure.

• Accountability:

Head QC                                     : For system compliance.

• Procedure:
  • Procurement of analytical Column:
    • Procure the column as per the requirement in the method of analysis.
    • Ensure the column dimension, packing material; particle size and make are as per user requirement.
    • On receipt of the new column verify the information as per PO. Physically check the column for the following:
    • No damage
    • Dimensions (length, diameter) match as per PO.
    • Packing and particle size matches as per PO.
    • Write the date of receipt on the certificate of the Column.
    • On receipt of GC Columns enter the details in column Inward register. It contains the details like Date of receipt, Name of column, Dimension / Particle size, Column Sr. No. / Lot No/Batch No., Date of Issuance and date of Destruction.
    • Column number shall be assigned serially for GC.

• Suitability verification:
  • Perform for intended product when required.
  • Enter the information in issuance register
  • Connect the column to GC system.
  • Conditioned the GC column for 30 minutes before starting and after completion of analysis.
  • Check and record the system suitability parameters as per STP.
  • If the system suitability parameters are within acceptance criteria, the column passes the system suitability test.
  • The Performance Certificate received along with the column is reviewed and attached with the System Suitability report of first analysis.
  • If the column fails the system suitability test it shall be rejected, a record shall be maintained and column shall be returned back to purchase department.
  • Head QC/Authorized person shall approve column performance report.
  • Conditioning of column
    • Set the oven temperature to 240ºC and conditioned the new column for 120 minutes.
  • Use of column
    • Select the column which is required as per STP. Make entry in the log book in Annexure-III for the column and record the usage details.
    • Follow the STP for the test to be carried out.
  • Destruction of column
    • Initially column conditioning may be performed to resolve the issues related to peak elution.
    • If column conditioning is not able to resolve the peak related problem then it shall be decided to discard the column.
    • QC-Head shall takes the decision to discard the column and enter the details in column Inward register.
• Annexure
• NA

• Reference (S)

In house

• Glossary

A.R.No.                   : Analytical Report Number

B.No.                        : Batch Number

DMSO                    : Dimethyl Sulphoxide

HPLC                     : High performance liquid chromatography           

QA                          : Quality Assurance

QC                         : Quality Control     

RSD                       : Relative Standard Deviation

SOP                       : Standard Operating Procedure

STP                        : Standard test procedure

PO                          : Purchase order

• Revision History

Rev. No.	Details of changes	Reason for change