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

1.0 Purpose:

2.0 Scope:

3.0 Responsibility:

4.0 Definitions:

5.0 Procedure:

6.0 Acceptance Criteria:

7.0 Frequency:

8.0 Format for recording:

To lay down a procedure for Receipt, Handling, Qualification and Numbering of Gas Chromatography (GC) Column.

The scope of this SOP is applicable for Receipt, Handling, Qualification and Numbering of Gas Chromatography (GC) Column at [company name].

QC-Personnel: To raise the Requisition, maintain the inventory, Evaluation of column performance and Numbering of column.

Head-QC/Designee: To Monitor the Activity. Ensure the compliance of SOP.

5.1 Receipt of the GC columns shall be in accordance with the requisition raised by the Quality Control Department.

5.2 Ensure that the GC columns received are along with the manufacturer certificate and challan.

5.3 Place the GC column in appropriate storage conditions under lock and key.

5.4 GC columns shall be qualified for the product for which they are procured.

5.5 Follow the instructions provided by the supplier.

5.6 Columns received from R&D shall be qualified as per the qualification procedure and receipt shall be entered in the R&D Column Receipt Register.

5.7 GC column conditioning shall be done before every analysis until a flat baseline is obtained.

5.8 Handle the GC column carefully.

5.9 Care shall be taken while discarding the GC column.

5.10 For procurement of columns in the laboratory:

• The QC person shall raise the requisition of required GC columns in SAP.

• Purchase shall procure and deliver the column to the concerned person.

5.11 For receipt of columns or new columns in the laboratory:

• Issue the column from store along with challan.

• Check if the column specification is right or not and sign the challan as “Received By”. If the column does not match the requirement, put a remark as ‘Not received’ with proper reason and sign it. Prepare a challan and forward it to stores for further processing.

• After receiving the column in Quality Control Laboratory, concerned analyst shall do qualification of the column as per qualification procedure.

• After qualification, if performance tests are within limit, QC person shall allocate number and dedicate product name as per numbering procedure.

• If columns do not comply with system suitability test, those columns shall be rejected or sent back to party.

• Affix label on column showing Column Number.

• Record details of Column in Register.

5.12 Qualification Procedure:

• Before usage of column for first time, system suitability criteria of intended test in product shall be confirmed.

• Subjected column shall meet all system suitability criteria prior to routine analysis.

• Column qualification shall be documented in column qualification protocol.

• If column performance is found satisfactory, then column shall be issued for analysis by Head QC or designee and put initial in column of “Date in use” in “Column Inventory/Index”.

5.13 Numbering Procedure: Numbering for new Gas Chromatography (GC) column is given as follows:

[Define numbering system as per company policy]

The Column is said to be qualified if it meets the system suitability criteria given for the particular test in the product.

On Receipt of New column and whenever required.

Column No.

Reason for Rejection

Rejected By

Discarded By

Checked By

Remarks

8.1 Format for “Column Usage Logbook”.

Column Description:

Column No.:

Date

GC Column Usage Time Start Time

End Time

Name of Product/ Material

Test

Batch No.

No. of Injection Per Analysis

Cumulative

Performance %RSD

Theoretical Plate

Tailing Factor

Resolution

Analyst

Checked By

Remark

8.2 Format for “Analytical Protocol of GC Column Qualification”.

Analytical Protocol of GC Column Qualification

Column Type :

Column Number :

Qualification Date :

Product :

Test :

Reference Specification No. :

Reference Specification Rev. No. :

System Suitability :

Resolution Observed value	Limit	Theoretical Plates Observed value	Limit	Tailing Factor Observed value	Limit	Observed Value % RSD	Limit

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

—	Qualified By	Checked By	Approved By
Signature
Date
Department

8.3 Format for “GC Column Receipt Register”.

Sr. No.	Receipt Date	Column Description	Column no.	Received By/Date	Checked By/ Date

8.4 Format for “Column Rejection Logbook”.

8.5 Format for “GC Column Rejection / Destruction Report”.

Column No . (In-House) :

Make :

Dimension :

Particle Size :

Sr. No . :

Dedicated For :

Test :

Total no. of Injections:

Date of Issuance :

Date of Destruction :

System suitability parameter	Limit	Observed

—	Done By	Checked By
Signature
Date
Department

8.6 Format for “R&D Column Receipt Register”.

Sr. No.	Receipt Date	Product Name	Column Description	Column No.	Received By/Date	Checked By/ Date