SOP FOR PREPARATION OF SOLUTIONS

I.                   PURPOSE

To describe a procedure for preparation of solutions.

II.                SCOPE

This procedure is applicable for solutions in Quality Control department,

III.             RESPONSIBILITY

Assistant, Executive –Quality Control

IV.             ACCOUNTABILITY

Incharge - Quality Control

V.                PROCEDURE

1.0        For the preparation of solution, use previously boiled and cooled purified water.

2.0        For the preparation of solutions use A.R grade materials. Prepare the required solution as 

per IP/BP/USP and In house specification.

3.0        Record all the preparation details in the ‘Solution preparation record’

            Format No.: F01/SOPQC011-00.

4.0        Affix the “SOLUTION ” label on the bottle.           

5.0        Store the solutions in clean dry glass bottles. Store light sensitive solutions in amber

colored  glass bottles.

6.0        Each solution is allotted shelf life (use before date) of 30 days. 

7.0        Solution should not be used after the ” use before date”, during this period if any change

is  observed  in visual appearance, discard the same.

8.0        Label the solution properly with complete details.

9.0        If commercially available solution is procured, then affix  “REAGENT” label .

            10.0      List of Formats

Format No.	Title
F01/SOPQC011-00	Solution preparation record
F02/SOPQC011-00	Mobile phase preparation record

VI.       REVISION SUMMARY

Version No.	Revised on	Reason for Revision
00	NA	NA

 

END OF THE DOCUMENT