The Product Quality and Compliance Department at FHI 360 ensures that global health commodities comply with international standards for quality, safety and efficacy and perform as claimed by the manufacturer.
Established in 1989, the department provides comprehensive quality assurance and quality control services for a wide range of global health products, including pharmaceuticals, medical devices, in vitro diagnostics and vector control commodities. Our clients include government agencies, multilateral organizations, nongovernmental and development organizations, and private industry.
We focus on holistic risk management to provide the best value to our clients and the lowest risk to patients and end users. Our risk-based quality assurance services include the following (see our fact sheet (PDF) for additional details):
- Product and supplier qualification
- Supplier audits and evaluations
- Product quality incident and recall management
- Product quality control (sampling, inspection, testing and evaluation)
- Research and innovation to identify new quality control methods and technologies
- Technical assistance to strengthen regulatory functions of health systems and increase access to quality-assured medical products in low- and middle-income countries
The Product Quality and Compliance Department is ISO 9001 certified by BSI (certificate number FM 732783). FHI 360’s North Carolina laboratory is American Association for Laboratory Accreditation (A2LA) accredited to ISO/IEC 17025 (certificate number 0367.01). The Bangkok laboratory is accredited to ISO/IEC 17025 by the Thailand Bureau of Laboratory Quality Standards (certificate number 1099/50).
We have a long history of collaborative relationships with global quality assurance stakeholders and participate in global conferences and multilateral meetings. FHI 360 is a member of the International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM) International and the African Medicines Regulatory Harmonization Partnership Platform. We work with industry leaders to develop internationally recognized standards for products and testing.
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).