Procedure for Stability Testing of Products under Emergency Use Authorization

1) Purpose

The purpose of this SOP is to establish a procedure for conducting stability testing for products under Emergency Use Authorization (EUA) in compliance with regulatory guidelines. This ensures that products maintain their quality, safety, and efficacy throughout the duration of their emergency use.

2) Scope

This SOP applies to all personnel involved in the stability testing of products authorized for emergency use, including quality control, product development, and regulatory affairs teams.

3) Responsibilities

Product Development Team: Responsible for developing formulations suitable for emergency use and selecting appropriate packaging.
Stability Study Team: Responsible for conducting stability studies as per the EUA guidelines.
Regulatory Affairs Team: Responsible for ensuring compliance with EUA requirements and submitting stability data to relevant regulatory bodies.

4) Procedure

4.1 Protocol Development

4.1.1 Develop a stability testing protocol specifically designed for products under EUA,

considering accelerated conditions and reduced testing timelines.

4.1.2 Define testing parameters such as assay, sterility, pH, and degradation products under the specified conditions.

4.2 Sample Preparation and Storage

4.2.1 Prepare samples in the final packaging intended for emergency distribution.

4.2.2 Store samples under accelerated and real-time conditions as specified in the EUA guidelines.

4.3 Conducting Stability Tests

4.3.1 Perform stability tests at predefined intervals, considering the reduced timeline for EUA products.

4.3.2 Record all data accurately and ensure compliance with the approved protocol.

4.4 Data Analysis and Reporting

4.4.1 Analyze stability data to identify any trends or deviations that may impact product quality during emergency use.

4.4.2 Prepare a stability report to be submitted to the relevant regulatory authority for continued EUA approval.

5) Abbreviations, if any

EUA: Emergency Use Authorization
QA: Quality Assurance

6) Documents, if any

6.1 EUA stability testing guidelines
6.2 Stability testing protocols
6.3 Data collection sheets

7) Reference, if any

FDA Guidance for Industry: Emergency Use Authorization for Medical Products, Stability Testing Guidelines

8) SOP Version

Version 1.0