Product quality and compliance

product examples

FHI 360's state-of-the-art quality and compliance laboratories ensure that when products reach beneficiaries, they meet strict international quality standards. Our laboratory facilities in North Carolina, USA, and Bangkok, Thailand, test male and female condoms, oral and injectable contraceptives, intrauterine devices (IUDs), microbicides, antiretrovirals, antimalarials, insecticide-treated bed nets, essential medicines and other health products.

Our quality assurance staff has the necessary manufacturing, product development research and risk management experience to effectively manage product quality from manufacturing to the end user. Our skilled laboratory staff includes chemists, biologists and certified auditors. We follow more than 150 standard operating procedures for sampling, testing, auditing and managing programs, and we adhere to the International Organization for Standardization/International Electrotechnical Commission’s ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories. FHI 360’s U.S.-based laboratory is ISO 17025 accredited to test IUDs and male and female condoms per the American Association for Laboratory Accreditation (A2LA) certificate number 0367.01. Our Bangkok laboratory is accredited by Thailand's Food and Drug Administration.

In addition to testing product quality, we harness the technical knowledge and experience of our staff to assist procurement agencies, respond to product complaints and supply chain challenges, and assist country government laboratories.

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Product quality and compliance