SOP for Preparation of Reagent Solution : Pharmaceutical Guidelines

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SOP for Preparation of Reagent Solution

Standard operating procedure to prepare the reagent solutions for chemical analysis in quality control laboratory.

1.0 OBJECTIVE

To lay down the procedure for preparation of Reagent solutions.

2.0 SCOPE

This SOP shall be applicable to Quality Control Dept.

3.0 RESPONSIBILITY

Quality Control Supervisor

4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance

5.0 PROCEDURE

5.1 The solution shall be prepared by the chemist who actually does the analysis. The solution shall be prepared when it is required.
5.2 The quantity of the reagent depends on the requirement of the test.
5.3 The procedure shall be followed for preparing solution, which is laid down in the Appendix of respective Pharmacopoeias.
5.4 Distilled water shall be used for the preparation of reagent.
5.5 Storage condition for reagent shall be followed as specified, and light resistant bottles, refrigerator etc. shall be used wherever required.
5.6 All the reagent solution shall be stored stating the name of the solution, strength, normality, molarity (if there), prepared by name, sign, date of preparation and to be used before.
5.7 Once the solution is prepared it can be used for 3 months after the date of preparation.
5.8 If anything found incorrect within 3 months it shall be replaced by the fresh solution and prepared as and when required.
Related: Determination of Shelf Life of Solutions in Laboratory

6.0 ABBREVIATION

6.1 SOP: Standard Operating Procedure
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