Product quality and compliance

Product quality and compliance at FHI 360 is dedicated to ensuring that global health commodities meet high standards to limit the risk of products of inadequate quality and to increase protection for the end user.

The product quality and compliance department was established in 1995 to provide comprehensive product quality assurance and technical assistance to the contraceptive procurement and distribution programs of the U.S. Agency for International Development. Since then, our scope has expanded to include a broad set of clients and a wide spectrum of pharmaceuticals and medical devices.

We provide quality assurance services on essential health products, including male and female condoms, oral and injectable contraceptives, intrauterine devices, microbicides, antiretrovirals, antimalarials, insecticide-treated bed nets, essential medicines, laboratory supplies, instrument-based diagnostics, rapid test kits, voluntary medical male circumcision, and other procedural kits and food by prescription.

QUALITY ASSURANCE STRATEGY

We focus on comprehensive risk management to provide the best value to clients and lowest risk to patients and end users. Our staff has the technical expertise to guide organizations, manufacturers and governments through compliance with international standards and to assist decision-makers with regulatory issues, including proper manufacturing procedures, technical staffing, product use and complaint resolution. We perform vendor prequalification, including audits and technical reviews, and we manage product quality incidents and complaints such as product recalls. We also conduct stability studies to model the impact of suboptimal storage conditions.

STATE-OF-THE-ART QUALITY AND COMPLIANCE LABORATORIES

FHI 360 provides independent testing and consultancy services to ensure that when products reach beneficiaries, they meet strict international quality standards. Our laboratory facilities are in Durham, North Carolina, U.S., and Bangkok, Thailand.

Accreditations include:

American Association for Laboratory Accreditation (A2LA) accredited to International Organization for Standardization (ISO)/IEC 17025 per certificate number 0367.01 (U.S.)
Thailand Bureau of Laboratory Quality Standards per certificate MOPH 0621/04/0980 accredited to ISO/IEC 17025 (Thailand)

To keep our technology and technicians current, we routinely initiate and participate in sanctioned interlaboratory proficiency trials. Our highly trained staff adhere to good laboratory practices (GLP), which ensures that we stay accredited and that test results are consistent, reliable and accurate.

TECHNICAL LEADERSHIP

As a leader in quality assurance, we harness our knowledge and experience to provide guidance and training to organizations, manufacturers and government agencies, and we offer technical assistance to laboratories, retention stores and regulatory staff around the world. We leverage elements of our risk-based approach to quality assurance to provide tailored short- or long-term assistance to develop the capacity of local supply chains in resource-constrained settings.

COLLABORATION

We have a long history of collaborative relationships with global quality assurance stakeholders and participate in standards and industry meetings, global conferences and multilateral meetings. FHI 360 is a member of ISO and the American Society for Testing and Materials (ASTM) International, and we work with industry leaders to continue to develop internationally recognized product and test standards. Our technical expertise drives us to identify innovative approaches to quality assurance, including new methods and technologies, and to collaborate with other experts to improve the quality and availability of global health commodities.

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Product quality and compliance