StabilityStudies.in

Standard Operating Procedure for Compliance with US FDA Stability Testing Requirements

1) Purpose

The purpose of this SOP is to establish a standardized procedure for conducting stability testing of drug products to ensure compliance with US FDA stability testing requirements, thereby confirming the quality, safety, and efficacy of the products throughout their shelf life.

2) Scope

This SOP applies to all drug substances and products manufactured, tested, or stored within the facility for which stability data is required to meet US FDA requirements. It is relevant to departments involved in production, quality control, quality assurance, and regulatory compliance.

3) Responsibilities

• Quality Control (QC) Team: Performs stability testing according to FDA guidelines.
• Quality Assurance (QA) Team: Reviews and approves protocols and ensures compliance with FDA requirements.
• Regulatory Affairs Team: Ensures all stability data meets FDA submission standards.

4) Procedure

1. Preparation of Stability Protocol
   1. Develop a protocol outlining
      

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      storage conditions, test intervals, and analytical methods in line with FDA guidelines.
   2. Submit the protocol for review and approval by the QA team.
2. Execution of Stability Studies
   1. Store samples under specified conditions (e.g., 25°C/60% RH, 30°C/75% RH) in designated stability chambers.
   2. Conduct analytical tests at each defined time point to assess stability parameters.
   3. Record and document all test results, observations, and any deviations from the protocol.
3. Data Analysis and Reporting
   1. Analyze stability data to ensure compliance with FDA requirements.
   2. Prepare a comprehensive stability report and submit it to the Regulatory Affairs team for final review and submission.

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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