Product quality and compliance

Product quality and compliance at FHI 360 is dedicated to ensuring that global health commodities comply with international standards for quality, safety and efficacy and perform per manufacturer claims.

Established in 1989, the product quality and compliance department provides comprehensive quality assurance and quality control services for a wide range of global health products, including pharmaceuticals, medical devices, in vitro diagnostics, vector control commodities and other critical health products. We provide these services to government agencies, multilateral organizations, nongovernmental and development organizations, and private industry.

We focus on holistic risk management to provide the best value to clients and lowest risk to patients and end users. Our risk-based quality assurance services include the following (see additional details in a fact sheet):

Product and supplier qualification through risk-based technical evaluations
Supplier audits and inspections based on internationally recognized standards
Product quality incident and recall management
Product quality control on independent sampling, inspection, testing and evaluation through FHI 360’s state-of-the-art testing laboratories and third-party sampling and testing providers
Product analytical research and innovation to identify new quality control methods and technologies that expand capabilities and efficiencies
Technical assistance to donors, collaborating agencies, commercial clients and other relevant stakeholders to strengthen regulatory functions of health systems and increase access to quality-assured medical products in low- and middle-income countries

We have a long history of collaborative relationships with global quality assurance stakeholders, and we participate in standards and industry meetings, global conferences and multilateral meetings. FHI 360 is a member of the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM) International. We work with industry leaders to continue to develop internationally recognized product and test standards. We are also a member of the African Medicines Regulatory Harmonization Partnership Platform to support regulatory harmonization with Africa and the global quality assurance community.

Our distinct capabilities and leadership in quality assurance are highlighted by the U.S. Agency for International Development (USAID) Global Health Supply Chain-Quality Assurance Program (GHSC-QA).

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Product quality and compliance