STABILITY STUDY TEMPLATE FOR NUTRITIONAL PRODUCTS

Document Location: Packaging - Stability Requirements

Alternate Name: Annex 2

Date Document Last Updated: N/A

Publisher: UNICEF

Date Uploaded to website:  Aug 2024

Overview

This template assists manufacturers to design stability studies for their commercial products and summaries the stability data. This stability template is derived from the Interagency stability requirements and should not be considered as an alternative to suppliers stability protocols and a complete report. This template provides manufacturers an example to select parameters for stability study. The parameters that are used for stability study of  Ready to Use Therapeutic Foods (RUTF’s) is provided as an example. It covers organoleptic, packaging integrity, formula used, storage condition, physical, chemical and microbiological parameters. Suppliers shall use the product specification of which stability study is being followed.  Important to note is that the testing methods and laboratory must be accredited.  

Overall, this template provides manufacturers with a checklist of organoleptic, physical, chemical, microbiological parameters and packaging integrity that need to be included in stability study for Ready to use Therapeutic Foods (RUTF’s) and other nutritional products.

Link to Document

Interagency Stability Study Template Nutritional Products