GC Columns (Gas Chromatography) Management

Standard Operating Procedure for Receipt, Issuance, Performance, Regeneration, Use, Cleaning, Storage and Rejection of GC Columns.

GC Column Management

1.0   Objective

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

2.0   Scope

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

3.0   Procedure for GC Columns Management:

    • Procurement of analytical GC Columns:

    • Procure the GC column as per the requirement in the method of analysis.
    • Ensure the GC 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 GC Columns.
    • On receipt of GC Columns enter the details in column Inward register as per Annexure-I.
    • 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 Columns for Example: GC/XXX/YY

Where:

GC – Gas Chromatograph   

XXX- Serial No. 001,002,003

YY – Current Year

    • GC Column System 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 in Annexure-II

Related : SOP for HPLC Column Management

    • 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 GC column

    • Set the oven temperature to 240ºC and conditioned the new column for 120 minutes.
    • Use of GC 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 GC 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 as per Annexure-I.

4.0   Annexures – GC Columns

Annexure I – Format for GC column Inward/Issuance/Destruction

Sr.No. Date of Receipt/ Receipt By Name of Column & make Column I.D. No Dimension / Particle size Column Sr. No. /Lot No./Batch No. Date of Issuance/ Issued by Date of Destruction/ Destruction by Destruction verified By

Remarks

Annexure II – Format for performance record of GC columns

Make                                     :

Serial No                               :

Dimension                            :

Date of Receipt                    :

Date of Performance           :

Used for the Analysis         :

          SYSTEM SUITABILITY CHECK

PARAMETERS

ACCEPTANCE LIMIT (As per STP)

RESULTS

Theoretical Plates
Tailing Factor
Resolution
Percentage of RSD

System suitability chromatogram is attached

Remarks: All the system suitability parameters are within / not within the range. Therefore, it is concluded that the column shall be accepted/rejected for the analysis.

Column No. (In house)

Performed By:                                           Reviewed By:                                             Approved By:

Date                                                               Date                                                                Date

Annexure III – FORMAT FOR GC COLUMN LOG

Name of the Column                 :                                                                                         Make of Column     :

Dimension                      :                                                                                                      Particle Size                  :

Column I.D. No.              :                                                                                                   Column received on      :

Sr.No

Date of analysis Product name B. No. / A.R No. No. of Injection Cumulative No. of Injection Used By Checked By

Remarks

Janki Singh

Mrs. Janki Singh is the professional pharmaceuticals Blogger. She has already posted more than #1000 articles on varrious topics at different blogging plateforms. Contact : guideline.sop@gmail.com