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Standard Operating Procedure for Stability Data Reporting in CTD Format
1) Purpose
The purpose of this SOP is to provide a standardized procedure for reporting stability data in the Common Technical Document (CTD) format for regulatory submissions to health authorities.
2) Scope
This SOP applies to all stability data that must be reported in CTD format for submissions to regulatory authorities such as the US FDA, EMA, and other international bodies. It is relevant to departments involved in regulatory affairs, quality assurance, and quality control.
3) Responsibilities
- Regulatory Affairs Team: Ensures stability data is compiled and
formatted according to CTD guidelines.
Quality Assurance (QA) Team: Reviews and approves data and reports before submission.
Quality Control (QC) Team: Provides validated data for inclusion in the CTD format.
4) Procedure
- Data Compilation
- Gather all validated stability data, including test results, storage conditions, and time points.
- Ensure data complies with regulatory guidelines for CTD submissions.
- Gather all validated stability data, including test results, storage
- Data Formatting
- Format data in the CTD Module 3.2.P.8 (Stability) section.
- Prepare summaries, tables, and graphs to clearly present stability data.
- Submission Preparation
- Compile a CTD-compliant stability report.
- Submit the report to the Regulatory Affairs team for review.
5) Abbreviations, if any
- CTD: Common Technical Document
- QC: Quality Control
- QA: Quality Assurance
6) Documents, if any
- Stability Data Package
- CTD Stability Report
- Submission Documentation
7) Reference, if any
- ICH M4Q: Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality
- FDA Guidance for Industry: CTD – Quality
8) SOP Version
Version 1.0
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