To lay down a procedure for handling and storage of HPLC and GC columns.
1.0 PURPOSE:
1.1 To lay down a procedure for handling and storage of HPLC and GC columns.
2.0 SCOPE:
2.1 This procedure is applicable for handling of HPLC and GC columns used in Quality Control Department.
3.0 RESPONSIBILITY:
3.1 Assistant -QC
4.0 ACCOUNTABILITY:
4.1 Executive-QC
5.0 PROCEDURE:
5.1 HPLC columns:
5.1.1 All columns shall be washed after completion of analysis.
5.1.2 Each column shall be given column-identification number.
5.1.3 The identified column number shall contain two parts as described below.
5.1.3.1 First part (two digits) contains identification of column.
5.1.3.2 Second part (three digits) contains serial number of the column.
LC 001
Note: If column serial no. exceeds 999 then it shall be continued to four digits.
Incase of cephalosporins intermediate laboratory the column numbering system shall be started with lab code “2 ”followed by three digits sequence number and continued to four digits.
Example: LC001, and if serial no. exceeds to four digits LC10001.
Cephalosporin intermediate lab:
Example: LC2001,and if serial no. exceeds to four digits LC20001.
5.1.4 All columns shall be stored in a designated place and end caps fixed on both ends.
5.1.5 In case if the system suitability parameters does not meet, column shall be regenerated.
5.2 GC columns:
5.2.1 All columns shall be conditioned after completion of analysis.
5.2.2 Each column shall be given column-identification number.
5.2.3 The identified column number shall contain two parts as described below.
5.2.3.1 First part (two digits) contains identification of column.
5.2.3.2 Second part (three digits) contains serial number of the column.
GC 001
Note: If column serial no. exceeds 999 then it shall be continued to four digits.
Incase of cephalosporins intermediate laboratory the column numbering system shall be started with lab code “2 ”followed by three digits sequence number and continued to four digits.
Example: GC001, and if serial no. exceeds to four digits GC10001.
Cephalosporin intermediate lab:
Example: GC2001,and if serial no. exceeds to four digits GC20001.
5.2.4 In case if the system suitability parameters does not meet, column shall be regenerated.
5.2.5 All columns shall be stored in a designated place.
5.3 Each column shall be maintained column usage log as per the format No.xxxxx.
5.4 Column usage logbook issuance shall be maintained as per the format No.xxxxx and issuance sequence shall be followed as below.
YY 0001
Example: The first column usage log book issuance number in the year 2006 starts with ‘ 060001’.
5.5 After regeneration of HPLC and GC columns shall be checked system suitability as per respective STP.
5.6 In case if the system suitability parameters does not meet, discard the column.
Note: Incase of cephalosporins intermediate laboratory the column numbering system shall be followed as mentioned below.
Handling, storage, gc columns, suitability, laboratory, exceeds
