SOP for Reporting Stability Data in Common Technical Document (CTD) Format

Guidelines for Reporting Stability Data in CTD Format

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the preparation and presentation of stability data in the Common Technical Document (CTD) format, as required by various regulatory authorities, including the US FDA, EMA, and other global markets. This SOP ensures consistency in the presentation of stability data across submissions.

2) Scope

This SOP applies to all personnel involved in the preparation, compilation, and submission of stability data for drug substances and drug products in the CTD format.

3) Responsibilities

Stability Testing

Team: Responsible for generating accurate stability data and ensuring it is documented correctly.

Quality Assurance (QA) Team: Responsible for reviewing and approving the stability data presentation in the CTD format.

Regulatory Affairs Team: Responsible for ensuring that the stability data package meets the requirements of the

regulatory authorities and is submitted correctly.

4) Procedure

4.1 Preparation of Stability Data

4.1.1 Conduct stability studies according to the approved protocols and ensure that all data generated is accurate, complete, and reliable.

4.1.2 Record data in stability data sheets, ensuring that all results, including any out-of-specification (OOS) findings, are clearly documented.

4.2 Compiling Stability Data in CTD Format

4.2.1 Review the CTD guidelines for Module 3: Quality, which outlines the presentation format for stability data.

4.2.2 Organize the stability data into sections as required by the CTD format, typically including:

3.2.S.7: Stability of the Drug Substance
3.2.P.8: Stability of the Drug Product

4.3 Formatting and Presenting Data

4.3.1 Prepare tables, graphs, and narratives summarizing the stability data, including results at each time point and storage condition.

4.3.2 Ensure that the stability data is presented in a clear, concise, and accurate manner, with appropriate units, abbreviations, and references.

4.4 Quality Assurance Review

4.4.1 Submit the compiled stability data package to the QA Team for review.

4.4.2 Address any discrepancies or omissions identified by the QA Team and revise the data package accordingly.

4.5 Submission to Regulatory Authorities

4.5.1 Prepare the electronic submission of the stability data package in the eCTD format.

4.5.2 Submit the stability data package electronically to the relevant regulatory bodies.

4.5.3 Retain a copy of the submitted data package and maintain all relevant records as per internal SOPs.

5) Abbreviations, if any

CTD: Common Technical Document
eCTD: Electronic Common Technical Document
QA: Quality Assurance
OOS: Out-of-Specification

6) Documents, if any

Stability data sheets, stability testing records, compiled stability data package, electronic submission records.

7) Reference, if any

ICH M4Q: Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality.

8) SOP Version

Version 1.0