نظام إدارة الجودة للمنتجات الصيدلانية في الجزائر

Abstract EN

This article aims to address the issue of quality management in the pharmaceutical industry in Algeria as one of the largest pharmaceutical markets in Africa, with the expectation that it will continue to expand in the years to come.

Enhancing confidence in the local pharmaceutical product and ensuring its competitiveness is based mainly on the quality assurance of medicines, which requires the achievement of good manufacturing practices in the pharmaceutical industry.

The study focuses on the legal, regulatory and technical elements of the quality management system for the pharmaceutical industry in Algeria.

It has shown that the National Laboratory for the Control of Pharmaceutical Products “LNCPP” was in charge of this system since 1993.

The “LNCPP” performed a continuous and accurate follow-up of the quality control laboratories of production units in various pharmaceutical factories in Algeria by using the “5M” approach.

In accordance with Decree 19-190, this task was transferred to the National Agency for Pharmaceutical Products “ANPP” since July 2019.

Besides, as the ISO certification is a mean of improving quality that is directed to all industry sectors, the study recommends that the ICH Q10 model for an effective quality management system for the pharmaceutical industry should be adopted and implemented in Algeria