Guidelines for Stability Study Reports for ANDA Submissions
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for preparing stability study reports for Abbreviated New Drug Application (ANDA) submissions to the United States Food and Drug Administration (US FDA). This SOP ensures that stability data is presented in a manner that meets regulatory requirements and supports product approval.
2) Scope
This SOP applies to all personnel involved in the preparation, compilation, and submission of stability data for ANDA submissions to the US FDA.
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 documentation.
Regulatory Affairs Team: Responsible for ensuring that the stability data package meets the requirements of the US FDA and is submitted correctly.
4) Procedure
4.1 Data Compilation
4.1.1 Collect all stability data generated from the
4.1.2 Review the data for completeness, accuracy, and any out-of-specification (OOS) results or trends.
4.2 Formatting and Presentation of Data
4.2.1 Organize the stability data into a logical format as recommended by the US FDA. This typically includes:
- Summary of stability study design (e.g., type of study, storage conditions, and time points).
- Tabular presentation of stability data, including test results at each time point and storage condition.
- Graphical representations (e.g., plots of assay results, degradation product trends, etc.).
- Discussion of results, including any trends, deviations, or OOS results, and investigations conducted.
- Conclusion regarding the product’s shelf life, storage conditions, and any necessary labeling information.
4.3 Quality Assurance Review
4.3.1 Submit the compiled stability data package to the QA Team for review.
4.3.2 Address any discrepancies or omissions identified by the QA Team and revise the data package accordingly.
4.4 Submission to the US FDA
4.4.1 Prepare the electronic submission of the stability data package in the eCTD format as per US FDA requirements.
4.4.2 Submit the stability data package electronically through the US FDA’s Electronic Submissions Gateway (ESG).
4.4.3 Retain a copy of the submitted data package and maintain all relevant records as per internal SOPs.
5) Abbreviations, if any
US FDA: United States Food and Drug Administration
ANDA: Abbreviated New Drug Application
OOS: Out-of-Specification
eCTD: Electronic Common Technical Document
ESG: Electronic Submissions Gateway
6) Documents, if any
Stability data sheets, stability testing records, compiled stability data package, electronic submission records.
7) Reference, if any
US FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products (Q1A(R2)), CFR Title 21, ICH Guidelines.
8) SOP Version
Version 1.0