SOP for Preparation and Sterilization of API and Excipients

SOP for Preparation and Sterilization of API and Excipients



Standard Operating Procedure for Preparation and Sterilization of API and Excipients in Nasal Spray Formulations

1) Purpose

The purpose of this SOP is to establish the process for preparing and sterilizing active pharmaceutical ingredients (APIs) and excipients used in nasal spray formulations to ensure sterility, consistency, and product safety.

2) Scope

This SOP applies to all personnel involved in the preparation and sterilization of APIs and excipients at [Company Name]. It covers materials for sterile nasal spray formulations.

3) Responsibilities

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