alexa The Three-Level Approach: A Framework for Ensuring Medicines Quality in Limited-Resource Countries | OMICS International | Abstract
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Review Article

The Three-Level Approach: A Framework for Ensuring Medicines Quality in Limited-Resource Countries

Victor S Pribluda1*, Adrian Barojas1,2, Veerle Coignez1, Sanford Bradby1, Yanga Dijiba1, Latifa El-Hadri1, Mustapha Hajjou1, Laura Krech1, Souly Phanouvong1, Karim Smine1, Kennedy Chibwe1, Patrick H Lukulay1 and Lawrence Evans III1

1Promoting the Quality of Medicines Program, Global Health Impact Programs, United States Pharmacopeial Convention, Rockville, MD, USA

2Currently at the Pan American Health Organization, Washington, D.C., USA

*Corresponding Author:
Victor S Pribluda
Promoting the Quality of Medicines Program
Global Health Impact Programs
United States Pharmacopeial Convention
12601 Twinbrook Parkway, Rockville, MD, 20852-1790, USA
Tel: 1-301-816-8258
E-mail: [email protected]

Received date: February 13, 2014; Accepted date: February 23, 2014; Published date: March 04, 2014

Citation: Pribluda VS, Barojas A, Coignez V, Bradby S, Dijiba Y, et al. (2014) The Three-Level Approach: A Framework for Ensuring Medicines Quality in Limited-Resource Countries. Pharmaceut Reg Affairs 3:117. doi:10.4172/2167-7689.1000117

Copyright: © 2014 Pribluda VS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Regulators from countries at all levels of income struggle to protect the public from the dangers of poor-quality (counterfeit and substandard) medicines. In particular countries with limited resources are at higher risk because of weak regulations, insufficient personnel, or  laboratories with poor infrastructure and a lack of equipment required to perform quality control analysis. A systematic approach is needed to address these gaps.

A stepwise process was used to design medicine quality monitoring programs in numerous countries in Africa, South America, and Southeast Asia. The experience gained in these countries resulted in the development of the Three-level Approach for performing quality control of medicines throughout the supply chain.

The approach consists of three successive, complementary, and increasingly complex levels of analysis: The first level includes visual and physical inspection to assess package and insert conditions and information as well as the physical characteristics of the actual medicines. The second level consists of rapid analytical tests that assess a limited number of quality attributes and can easily be performed in the field by trained personnel. The third level involves quality control testing according to the product’s registration specifications and is performed in an appropriate laboratory setting by experienced and trained analysts.

The Three-level Approach offers regulators in limited resource countries, a cost-effective high-throughput methodology for quality monitoring that produces valid and trustworthy results. The approach strengthens medicines quality assurance systems by allowing better regulation of the pharmaceutical market, which ultimately reduces the prevalence of poor-quality medicines.


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