• Centers of Excellence
• Country Assessments
• Drug Testing
• On–site Training
• Good Manufacturing Practices (GMP) Audit and Assistance
• TB Drug Dossier Review
• Drug Registration Practices
• Drug Information
• Continuing Education

In order to strengthen national and regional capacity in Asia to address issues related to the quality of essential medicines, USP DQI—with support from USAID's Mission in the Philippines and the Regional Development Mission/Asia (RDM/A) in Thailand—is establishing the Asian Network of Excellence in Quality Assurance of Medicines (ANE/QAM) in the area. By strengthening specific capacities of existing national institutions and linking them together to form a network, they can serve the needs of all the countries within the region. The ANE/QAM focuses on achieving three objectives:

• Building up local capacities in various fields of drug quality assurance;
• Develop and facilitate effective South–South cooperation by increasing access to technical experience and skills through a collaborative technical and information sharing mechanism; and
• Ensuring sustainability of the Centers' organization initially through technical assistance from USP DQI and, by supporting the network members,identify opportunities and provide technical services in the region.

Thus far, the network includes the following institutions and their specializations—

• Mahidol University—Good Manufacturing Practices (GMP) and stability studies
• University of Santo Tomas Center for Drug Research, Evaluation and Studies (UST CeDRES)—Bioavailability/bioequivalence (BA/BE) and pharmacopeial monograph/reference standard development
• Chulalongkorn Pharmaceutical System Research and Intelligence Center (PSyRIC)—Quality control

Photo by USP Staff

Upon request by a regional or country USAID Mission, a team of USP DQI drug quality specialists evaluates how a country's existing drug regulatory authority functions and how it might be improved with technical assistance and training. Assessment tools specially designed by USP DQI staff are used to obtain general information on the country's system, to collect data from the field on specific drugs, and to determine the current quality level of medicines in the marketplace.

• Rapid Assessment Tool  (251KB)—questionnaire devised to obtain general information and specific data for the assessment of a drug quality assurance program and drug quality control system to gauge a country's drug quality capacity.
• Drug Quality Monitoring Indicators  (198KB)—questionnaire designed to obtain evidence–based data from the field on the quality of selected drugs including standardized data, specific indicators available within the drug quality assurance, control, and information system.
• Sampling Guidelines  (197KB)—questionnaire intended to learn the incidence of good as well as bad quality medicines available in public and private supply and distribution; formal and informal channels; urban, suburban, and rural areas; and the main route of drug supply from neighboring countries.

Should the country seek further technical assistance, USP DQI works with the local Ministry of Health and national drug authority to develop a plan for obtaining more evidence–based data from the field on the quality of selected medicines. Once analyzed, the data is used to help national infectious disease programs—both government agencies and NGOs—develop and implement appropriate strategies that address the problems of counterfeit and substandard drugs, ultimately improving the quality of available medicines.

Photo by USP Staff

In many countries supported by USAID, data about the quality of medicines most often does not exist. In collaboration with regional and national health programs, USP DQI collects and tests drugs to establish a drug quality baseline, identifies sentinel surveillance sites, and helps establish drug quality monitoring at sentinel sites throughout the country or region. Collected drugs are monitored for quality, using low–technology screening methods by trained analysts, on a regular basis and test results are shared among stakeholders allowing corrective actions to be taken as necessary.

USP DQI teaches practical and simple methods for early detection of substandard antimalarial drugs to build drug quality assurance into national malaria, TB, and HIV/AIDS programs. Basic testing includes physical/visual examination of packaging and dosage forms, simple disintegration, and thin–layer chromatography (TLC), methods that allow field staff to determine the adequacy of labeling, the uniformity of dosage forms, and the identity and amount of active ingredients.

USP DQI collaborates with the World Health Organization (WHO), WHO Regional and Country Offices, and national health authorities to conduct training courses on a broad spectrum of enhanced drug quality measures. The courses—held on–site at national drug quality laboratories or at sentinel sites and local labs—focus on a wide range of topics related to various facets of drug quality at the regional, national, and local levels.

Photo by USP Staff

• Quality Assurance/Quality Control (QA/QC)

  Drug regulatory officials, laboratory personnel, and infectious disease control program staff are trained in sampling procedures to collect a representative selection of medicines to test for quality. USP DQI holds hands–on workshops—usually conducted in a native language—on how to follow good laboratory practices while using low–technology methods and techniques (physical/visual inspections, basic tests, simple disintegration, and thin–layer chromatography) to screen drugs for quality in the field and to properly report the data.

  Training–of–Trainer Workshops later are held to prepare participants to teach other local technicians in the techniques of good laboratory practices and commonly used methods for testing drug quality. Discussion in the workshops also focuses on the proper use and maintenance of laboratory equipment and the proper management and use of drug quality data. These procedures are essential to establishing a sustainable drug quality control system in the country.

Photo by USP Staff

• Minilab Testing

  The Minilab® is a self–contained mobile laboratory designed by the Global Pharma Health Fund (GPHF) that provides the essential lab ware, chemicals, and reference materials to quickly determine drug quality in non–laboratory settings. In tandem with its random sampling program, USP DQI places Minilabs® at sentinel sites, allowing personnel at the local/community/hospital/health program levels to regularly test drug quality in the marketplace. USP DQI staff trains users in basic testing methods (visual/physical inspection, disintegration, and Thin Layer Chromatography)–developed and validated specifically for the Minilab®–for antimalarial, anti–tuberculosis, antiretroviral, and some antibiotic medicines. With the monograph USP DQI developed on oseltamivir phosphate and oseltamivir capsules, the Minilab® can also be used to test the quality of medicines for Avian Influenza.

Photo by USP Staff

A priority of the USP DQI program is providing local drug manufacturers the technical assistance to comply with Good Manufacturing Practices, standards that must be followed throughout the life cycle of every product to assure good quality. USP DQI experts will assess laboratories for drug quality control capabilities; evaluate the staff, facilities, equipment, skills, procedures, and quality systems in place; define gaps and set priorities to address them; and provide guidance toward achieving higher levels of compliance with internationally accepted GMP standards.

USP DQI also conducts training workshops to enable health authorities, regulatory bodies, quality assurance departments, and others to better understand the need for GMP inspections and to effectively perform a GMP audit. Participants are trained in all facets subject to inspection and in various types of audits—internal, announced and unannounced, pre–approval and general regulatory GMP inspections—that assure facilities comply with GMP regulations. The course covers each step in the process, from how to prepare for an audit, to conducting onsite meetings, to following up for compliance. Improving the GMP status of local pharmaceutical manufacturers can complement a country's existing efforts to improve drug quality control systems and enhance national healthcare outcomes.

TB Drug Dossier Review

USP DQI develops targeted drug and therapeutic information materials for health care providers based on specific needs. In addition, the program offers assistance in establishing and equipping local drug information centers by working with local academic, government, nongovernmental, and professional institutions. More information.

To use antimicrobials appropriately, healthcare professionals require up–to–date knowledge about which antimicrobials are recommended to treat specific infections and about the factors that contribute to antimicrobial resistance. USP DQI, with Smolensk University, provides training for physicians, pharmacists, and nurses in drug information and pharmacovigilance to help improve drug dispensing and ensure competence and accountability. Many programs are conducted through the Distance Learning Project. More information.