Preparation of Reagents

1.0    PURPOSE:

1.1    To lay down the procedure for preparation of reagents, buffers and diluents used in quality control department.

2.0    SCOPE:

2.1    This procedure is applicable for Quality Control Department.

3.0    RESPONSIBILITY:

3.1    Junior Assistant/Senior Assistant – QC 
3.2    Senior Executive – QC 

4.0    ACCOUNTABILITY:

4.1    Manager – QC 
4.2    Asst. Manager – QC 
4.3    Senior Executive – QC 

5.0    PROCEDURE:

5.1    Reagent preparation details shall be entered in reagent preparation record as per Annexure – I for general reagents, buffers, diluents, etc.
5.2    All reagents unless otherwise specified in the individual procedure shall used with in three months from the date of preparation.
5.3    If any precipitation, sedimentation or haziness is developed in the reagent discard the reagent.
5.4    All reagents shall be stored at room temperature unless otherwise specified in respective procedures.
5.5    Reagents shall be labeled with the name of reagent, date of preparation, lot number, storage condition (when storage is required other than room temperature) and signature date.
5.6    Allotment of reagent lot number:
5.6.1    The first two characters are always last two digits of the current year.
5.6.2    ‘R’ represents the reagent.
5.6.3    ‘X’ represents lab code, 0 for the Lab-1(Non Cephalosporins QC), Lab-II(Cephalosporins QC) and Lab-III(F&G QC)
5.6.4    Next three characters shall be sequential numbers as allotted to the reagent.
5.6.5    The sequential number shall be restarted each year.
5.6.6    Example: The reagent number would be as follows:

xxxxx
5.6.7    Enter the following details in the register:
5.6.7.1    Serial number
5.6.7.2    Reagent Name
5.6.7.3    Lot Number
5.6.7.4    Date of preparation
5.6.7.5    Valid up to
5.6.7.6    Signature Date

Preparation, reagents, annexure, date of preparation, represents