SOP for Conducting Stability Studies for Drug Substances Under US FDA Guidelines

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SOP for Conducting Stability Studies for Drug Substances Under US FDA Guidelines

Standard Operating Procedure for Stability Testing of Drug Substances According to FDA Guidelines

1) Purpose

The purpose of this SOP is to outline the procedure for conducting stability studies for drug substances in compliance with US FDA guidelines to ensure their quality, safety, and efficacy throughout the intended shelf life.

2) Scope

This SOP applies to all drug substances manufactured, tested, or stored within the facility that require stability studies under US FDA regulations. It is relevant to departments involved in production, quality control, quality assurance, and regulatory affairs.

3) Responsibilities

  • Quality Control (QC) Team:
Conducts stability testing in accordance with FDA guidelines.
  • Quality Assurance (QA) Team: Reviews and approves stability protocols and reports.
  • Regulatory Affairs Team: Ensures stability data is formatted for FDA submissions.

    • 4) Procedure

    1. Preparation of Stability Protocol
      1. Draft a protocol detailing storage conditions (e.g., 25°C/60% RH, 40°C/75% RH), test

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        intervals, and analytical methods.
      2. Submit the protocol for review and approval by the QA team.
    2. Execution of Stability Studies
      1. Store samples in stability chambers under the specified conditions.
      2. Conduct analytical tests at each specified interval to assess stability parameters such as potency, degradation, and physical characteristics.
      3. Document all test results, observations, and any deviations from the protocol.
    3. Data Analysis and Reporting
      1. Analyze data to ensure compliance with FDA requirements for drug substances.
      2. Prepare a comprehensive report for submission to the FDA.

    5) Abbreviations, if any

    • QC: Quality Control
    • QA: Quality Assurance
    • FDA: Food and Drug Administration
    • RH: Relative Humidity

    6) Documents, if any

    • Stability Study Protocol
    • Analytical Test Reports
    • Stability Study Report

    7) Reference, if any

    • FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products

    8) SOP Version

    Version 1.0

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