Sunday 15 September 2013

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

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