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SOP for Receipt, Issuance, Performance and Storage of GC Columns

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 Analyst
QC Supervisor
QC Manager


Procedure

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:
  1. No damage
  2. Dimensions (length, diameter) match as per PO.
  3. 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 the column, Dimension / Particle size, and 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 the intended product when required.
  • Enter the information in the 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
  • 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 the first analysis.
  • If the column fails the system suitability test it shall be rejected, a record shall be maintained and the column shall be returned back to the purchasing 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 an 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 take the decision to discard the column and enter the details in column inward register as per Annexure-I.


Annexures

Revision History
Nil

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