Standard Operating Procedure for Stability Study Documentation for NDAs

1) Purpose

The purpose of this SOP is to provide a standardized procedure for documenting stability studies in support of New Drug Applications (NDAs) to the US FDA to ensure compliance with regulatory requirements.

2) Scope

This SOP applies to all stability studies conducted in support of NDAs to the US FDA. It is relevant to departments involved in regulatory affairs, quality control, and quality assurance.

3) Responsibilities

• Regulatory Affairs Team: Prepares stability study documentation for NDA submission.
• Quality Assurance (QA) Team: Reviews and approves stability study documentation.
• Quality Control (QC) Team: Provides validated data for NDA submissions.

4) Procedure

1. Data Compilation
   1. Gather all stability data, including test results, storage conditions, and time points.
   2. Ensure data is validated and compliant with FDA guidelines.
2. Document Formatting
   1. Format stability data according to FDA requirements, including summaries, tables, and graphs.
   2. Prepare a comprehensive stability
      

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      report, including all relevant data, analyses, and interpretations.
3. Submission Preparation
   1. Compile the stability documentation as part of the NDA package.
   2. Submit the NDA package to the Regulatory Affairs team for final review and submission to the FDA.

5) Abbreviations, if any

• NDA: New Drug Application
• QC: Quality Control
• QA: Quality Assurance
• FDA: Food and Drug Administration

6) Documents, if any

• Stability Data Package
• Stability Report for NDA Submission

7) Reference, if any

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

8) SOP Version

Version 1.0