SOP for Writing Method of Analysis for Packaging Material

1.0 OBJECTIVE

To clearly lay down the procedure for writing method of analysis for P.M.

2.0 SCOPE

This procedure is applicable for all P.M. in the quality control department.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant /Executive
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 After the receipt of new or revised specification from R&D, prepare respective method of Analysis.
5.2 Describe the procedure stepwise for each test to simplify the method.
5.3 In case of pharmacopoeial packaging material, prepare method of analysis as per respective test procedure of Pharmacopoeia.
5.2 After preparing the method, prepare a file for original method.
5.3 Review the MOA when any change in procedure or test in specification are amended by any pharmacopoeia or relevant source.

Related: SOP for Retesting Schedule of Packaging Material

6.0 ABBREVIATIONS

6.1 MOA = Method of analysis
6.2 PM = Packaging Material
6.3 R&D = Research & Development

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