SOP for Procedure for Writing Method of Analysis for Packing Material

Objective

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

Scope

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

Responsibility

Doing: Technical Assistant /Executive

Checking: Executive /Manager

Accountability

Head of the Department

Procedure

• After the receipt of New or revised specifications from R & D, or prepared at PharmaInfo, Prepare the respective method of Analysis at PharmaInfo as per the annexure.
• Describe the procedure stepwise for each test to simplify the method.
• In the case of pharmacopoeial packaging material, prepare the analysis method as per Pharmacopeia's respective test procedure.
• After preparing the method, prepare a file for the original method.
• Review the MOA when any change in procedure or test in the specification is amended by any pharmacopeia or relevant source.

Annexure

Abbreviations

MOA = Method of analysis

PM = Packaging Material

R & D = Research & Development

Revision History

Nil

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