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 |
|