To lay down a procedure for receiving HPLC columns registering and its usage.
This SOP is applicable to Quality Control Department.
Quality Control Executive / Officer.
5.1 On receipt of a new column, enter the following details in the HPLC column register.
A. Name of the column.
C. Dimension and its particle size
D. Date of receipt
E. Mfr. Certificate : Received / Not received
G. Manufacturers column number
H. Column number allotted
I. Usage with effective from (w.e.f.) [date]
5.3 All new columns in the lab should be numbered at the time of receipt.
5.4 Q.C Executive/Officer will be responsible to allot the number on receipt of the column.
5.5 All new columns / spare columns should be kept properly under lock & key and columns under usage shall be kept in allotted places.
5.6 Five digit alpha numeric is designed to number the column, for example F3HC000,
Where F3 represents Formulations 3 Quality control, HC represents HPLC Column and 000 is a serial number,Which represents the column serial number 001 to 999
5.7 Depending up on the Specificity of the column, its application is decided immediately
or prior to use. The same has to recorded in the HPLC columns register.
5.8 If the column Performance is found unsatisfactory as per analytical method, the same
Should be discarded from the routine usage, and The same column should be labeled and kept separately for its regeneration or destruction.
5.9 After regeneration, if a column performance is found satisfactory , the column has to be kept for usage again.
5.10 If the column performance is not satisfactory, the column should be labeled FOR DESTRUCTION and record of such columns should be maintained
5.11 New column will be issued to the laboratory after proper authorization.