StabilityStudies.in
Standard Operating Procedure for Compiling Stability Data for FDA Submissions
1) Purpose
The purpose of this SOP is to provide a standardized procedure for preparing and compiling stability data in a format suitable for submission to the US FDA to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
2) Scope
This SOP applies to all drug products for which stability data is required to be submitted to the US FDA. It is relevant to departments involved in quality control, quality assurance, regulatory affairs, and production.
3) Responsibilities
- Regulatory Affairs Team: Ensures that all stability data
is compiled and formatted according to FDA guidelines.
Quality Assurance (QA) Team: Reviews and approves stability data before submission.
Quality Control (QC) Team: Provides validated test results and data for submission.
4) Procedure
- Data Compilation
- Gather all stability data, including analytical test results, sample storage conditions, and time points.
- Ensure data is validated and complies with FDA requirements.
- Gather all stability data, including analytical test results,
- Data Formatting
- Format data in accordance with FDA guidelines, using the Common Technical Document (CTD) format, if applicable.
- Prepare summaries, tables, and graphs to clearly present stability data.
- Submission Preparation
- Compile a stability report including all data, analyses, and interpretations.
- Submit the report to the Regulatory Affairs team for review.
5) Abbreviations, if any
- FDA: Food and Drug Administration
- NDAs: New Drug Applications
- ANDAs: Abbreviated New Drug Applications
- CTD: Common Technical Document
6) Documents, if any
- Stability Data Package
- Stability Report
- Submission Documentation
7) Reference, if any
- FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
- FDA Submission Requirements for NDAs and ANDAs
8) SOP Version
Version 1.0
StabilityStudies.in