SOP for Writing Method of Analysis for Packaging Material : Pharmaceutical Guidelines

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SOP for Writing Method of Analysis for Packaging Material

Standard operating procedure to write the 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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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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