Guideline for Good Storage Practices, Good Distribution Practice, and Pharmaceutical Product Recall. First Edition, September 2015 - Ethiopia
(2015; 71 pages)

EFMHACA would like to acknowledge the United States Agency for International Development (USAID) and the U. S. Pharmacopeial Convention Promoting the Quality of Medicines (PQM) Program for the financial and technical support delivered in preparation of this Guidance.

Abstract

EFMHACA has prepared these guidelines because the quality and integrity of pharmaceutical products and materials can be affected with lack of control during storage and poor compliance to good storage practices.

This guide is intended for those involved in the storage, transportation and distribution of pharmaceuticals. It is closely linked to other existing guidelines of the Food, Medicine and Healthcare Administration and Control Authority of Ethiopia (EFMHACA) and other recognized guidelines of the World Health Organization (WHO) or The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The objective of this guide is to describe the minimum requirements considered appropriate for the storage and transportation of pharmaceuticals products and materials so that to avoid safety, efficacy and quality problems caused by improper storage practice of pharmaceutical products and materials.

These guidelines are applicable not only to manufacturers of medicinal products, but also to pharmaceutical importers, wholesalers, medicine retail outlets and hospital pharmacies as well as other facilities which stores medicines. They should be adjusted in line with the type of activity where the storage of pharmaceuticals is taking place.

 
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