The core work of the Product Quality and Compliance (PQC) Division is to test contraceptive devices and pharmaceuticals. Family Health International (FHI) has extensive experience in this area and is a collaborating partner with the World Health Organization (WHO). Additionally, we are increasingly evaluating other products such as antiretrovirals, antimalarials, microbicides, and bed nets.
FHI's Product Quality and Compliance Division provides high-quality, independent testing and consultancy services to manufacturers, distributors, retailers, and governments to ensure that the medical devices and pharmaceuticals that reach consumers meet international quality standards. Since 1990, the Product Quality and Compliance Division has worked with FHI's researchers, international aid agencies, and manufacturers to improve product quality and reliability.
Our technical expertise can guide organizations, manufacturers, and governments through compliance with international standards, and assist decision makers with regulatory issues, including proper manufacturing procedures, technical staffing, product use, and complaint resolution.
Our client list includes U.S. Agency for International Development, UN Population Fund, DKT International, International Planned Parenthood Federation, Population Services International, and major product manufacturers.
Please see the brochure (PDF, 504 KB) about our product quality and compliance capabilities for more information. Also see the second issue of our newsletter, Research in Public Health (PDF, 232 KB), which focuses on our work in this area.
For further information, please send us an email.
Learn more about PQC:
Product Evaluations and Consultancy Services
Accredited Laboratories
Interlaboratory Trials
Contact PQC
Product Evaluations
Family Health International's state-of-the-art testing laboratories can provide you with the information you need to make informed decisions on:
- Male/Female condoms
- Medical gloves
- Intrauterine devices
- Oral/Injectable contraceptives
- Implants
- Spermicides/microbicides
- Antiretrovirals
- Antimalarial drugs and bed nets
- Product compatibility
- Multivitamins
- Deworming drugs
Consultancy Services
Family Health International's knowledgeable and highly skilled staff are available to help you make informed decisions about:
- Import detentions
- Product stability and shelf-life studies
- Laboratory setup and operations
- Prototype design and evaluation
- Product capabilities
- Regulatory issues and submissions
- Product characterization
- Standard operating procedures, test methods, and sampling protocols
Please contact us for more information or a price quote.
Accredited Laboratories
Durham, North Carolina, USA
FHI's state-of-the-art testing facility in Durham, North Carolina, offers a full range of product evaluations and consultancy services. The physical testing laboratory is accredited to ISO/IEC 17025(2005) by the American Association for Laboratory Accreditation (A2LA) (PDF, 1.25 KB). Product evaluations are conducted using international standards and specifications from ISO, ASTM, USP, and WHO. The facility complies with industry standards, and our on-site lab technicians and chemists adhere to good laboratory practices in their evaluations of medical devices and pharmaceuticals.
Bangkok, Thailand
FHI's state-of-the-art testing facility in Bangkok, Thailand, offers male condom evaluations (sampling and testing) and conducts product evaluations using international standards and specifications from ISO, ASTM, and WHO. The physical testing laboratory is accredited to ISO/IEC 170025(2005) by the Bureau of Laboratory Quality Standards, Department of Medical Sciences, Ministry of Public Health, Royal Thai Government (PDF, 194 KB). The facility complies with industry standards, and our on-site lab technicians adhere to good laboratory practices in their evaluations of male condoms.
Interlaboratory Trials
FHI performs interlaboratory trials on male condoms on an annual basis. Participating laboratories are able to see where they are statistically compliant and/or where more improvement is needed. They are also able to see how they anonymously compare to other laboratories.
For more information on the trials, or if you are interested in participating, please contact us using the information below.
Contact PQC
USA
Product Quality and Compliance Division
Family Health International
2810 Meridian Parkway, Suite 133
Durham, NC 27713
Telephone: +1-919-544-4070 X 11665
Fax: +1-919-544-5849
E-mail |
Thailand
127 South Sathorn Road
Tungmahamek, Sathorn
Panjaphum 2 Building, 9th Floor
Bangkok 10120
Telephone: +66-02-285-5505
Fax: +66-02-285-5149
E-mail |
