FHI 360 is the prime contractor for the USAID Global Health Supply Chain - Quality Assurance Program (GHSC-QA). The program is led by FHI 360’s Product Quality and Compliance (PQC) department based in Durham, North Carolina. GHSC-QA provides independent, essential, comprehensive quality assurance services covering the different health elements in the USAID Global Health Bureau that:
- Assures that health commodities purchased on behalf of USAID meet applicable quality standards;
- Implements Model Quality Assurance System (MQAS) guidance (WHO Technical Report Series);
- Employs risk management practices to maintain diligence and recognizes that by limiting the risk of accepting products of inadequate quality increase protection of the end user and USAID is ensured.
- Provides technical assistance and capacity building to host country governments and other stakeholders;
- Provides global technical leadership regarding quality issues to the international quality assurance community;
GHSC-QA implements a risk-based approach to provide the best value for USAID. GHSC-QA regulatory and quality assurance professionals evaluate products for procurement, conduct cGMP audits, investigate product quality incidents and complaints, perform testing of health commodities, and provide technical assistance to National Drug Regulatory Authorities (NDRAs) and laboratories around the world. With global activities spanning nearly 40 countries, GHSC-QA provides quality assurance on health commodities procured by USAID including:
TO1 – HIV Commodities
- Antiretrovirals (ARVs)
- Essential medicines
- Food by prescription (FBP) and ready-to-use therapeutic foods (RUTFs)
- Male and female condoms and personal lubricants
- Voluntary medical male circumcision (VMMC) kits
- HIV and non-HIV rapid test kits (RTKs)
- Laboratory supplies
TO3 – Reproductive Health Commodities
- Oral contraceptives
- Injectable contraceptives
- Intrauterine devices (IUDs)
- Pregnancy test kits
TO4 – Maternal and Child Health Commodities and Zika
- Essential medicines for infants and children
- Specific products for Zika
GHSC-QA is comprised of four objectives:
Objective 1: Quality Assurance
GHSC-QA is dedicated to ensuring that global health commodities meet high quality standards to limit the risk of products of inadequate quality and to increase protection for the end user. GHSC-QA’s quality assurance strategy includes product risk assessments, performing audits and technical reviews, managing product quality incidents and complaints such as product recalls, vendor prequalification, and managing approved supplier/product lists. The eligible lists available to the public are hyperlinked at the bottom of the page. Technical advisory groups (TAGs) are convened to provide advice and expertise to USAID regarding the quality assurance program (QAP) and in addressing quality issues. Comprehensive risk management practices and regulatory expertise assure product compliance and a robust technical review process identifies poor quality products and prevents these from reaching the market.
To report a product quality complaint: GHSCQA@fhi360.org
Objective 2: Quality Control
GHSC-QA’s quality control (QC) strategy monitors the quality of health commodities procured on behalf of USAID. QC activities include: sampling and testing of products; establishing sampling and testing ratios; developing standardized testing protocols; monitoring results of testing; and implementing actions based upon the results of QC testing. With global sampling capabilities, GHSC-QA can sample products in most countries, including fragile states, depending on the current environment. GHSC-QA has the capacity to test family planning and reproductive health, HIV/AIDS, maternal and child health commodities, and laboratory supplies.
State-of-the-art testing laboratories in Durham, North Carolina and Bangkok, Thailand are both accredited to International Organization for Standardization (ISO) 17025. A network of vetted, qualified testing laboratories with laboratories in Africa, Asia, North America, and Europe provide a range of testing services that offer flexibility and increased testing capacity. To keep the laboratories’ technology and technicians current on cutting-edge practices, GHSC-QA routinely initiates and participates in sanctioned inter-laboratory proficiency trials and its highly-trained technicians and chemists adhere to good laboratory practices (GLPs) in their evaluations of medical devices and pharmaceuticals which ensures our accreditation and that test results are consistent, reliable, and accurate.
For questions or concerns about orders, sampling, and testing: GHSC-QA-Orders@fhi360.org
To report any quality or marketing issues related to oral contraceptive tablets with the Blue Lady logo, please contact BlueLadyInfo@usaid.gov.
Objective 3: Technical leadership and technical assistance
As a leader in quality assurance, GHSC-QA utilizes technical knowledge to engage with and provide technical support and training to partner country governments, USAID implementing partners, and other relevant stakeholders as requested and funded through USAID. Our technical expertise assists key stakeholders with product complaint resolution, product quality disputes, compliance with international standards and other regulatory issues related to health commodities. The type of technical assistance provided around the world includes, but is not limited to, in-country laboratory trainings; product technical assessments to determine level of risk and corresponding control strategies; ISO 9001 and 17025 accreditation trainings; developing risk-based surveillance programs to evaluate the quality of health commodities circulating in local markets; overseeing or providing guidance to conduct investigations around product quality concerns; evaluating level of compliance of local manufacturers, suppliers and distributors to WHO standards (cGMP, GDP, GSP). GHSC-QA provides these services for pharmaceuticals, medical devices (including in-vitro diagnostics), food by prescription, vector control commodities and others.
Objective 4: Collaborate with global partners
GHSC-QA collaborates with global QA stakeholders to ensure and improve product quality for all beneficiaries. GHSC-QA project staff regularly participate in standards and industry meetings, global conferences, and multilateral meetings with international agencies, regulatory bodies, and standard-setting organizations to improve access to quality health commodities. GHSC-QA works with industry leaders to continue to develop internationally recognized product and test standards. GHSC-QA technical expertise drives us to identify innovative approaches in the field of QA, including new methods and technologies, and to collaborate with other experts in the field to improve the quality and availability of global health commodities. GHSC-QA’s role in ensuring the procurement of quality health commodities also involves frequent and consistent communication and collaboration with USAID and GHSC programs.