The Three-Level Approach: A Framework for Ensuring Medicines Quality in Limited-Resource Countries
(2014; 8 pages)

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


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 developed by the Promoting the Quality of Medicines (PQM) program and 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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