Technical Assistance toward WHO Prequalification

USP DQI is assisting the Global Drug Facility (GDF) in its efforts to increase the availability of good quality second-line anti-tuberculosis (TB) medicines at an affordable price. To expedite the process of prequalification with the World Health Organization (WHO)—thereby expanding the pool of viable manufacturers—USP DQI will provide technical assistance to interested companies on the preparation of drug dossiers they submit to WHO with their "Expressions of Interest" (EOIs).

Currently there are not enough WHO-prequalified second-line TB medicines manufacturers and an inadequate supply of products to treat patients with multidrug-resistant TB. In order to ensure good-quality products, United Nations (UN) procurement agencies, Global Fund, and many international and nongovernmental organizations mandate that only medicines prequalified by WHO, or approved by stringent regulatory agencies, are suitable for procurement. Subsequently, a number of companies have applied to WHO for prequalification, putting considerable demand on the organization's resources.

The Expression of Interest that must be submitted to WHO for consideration requires the manufacturer to supply considerable technical information on each product in specific order as presented in the "Information for Applicants" section of the WHO Prequalification website. USP DQI will work with interested manufacturers to:

• Prepare their product dossier for submission to the WHO Prequalification Project in a manner that fulfills the requirements
  of the prequalification team;
• Facilitate discussions with WHO to remedy incomplete dossiers or to respond to WHO comments; and,
• Guide them onsite in complying with the principles and guidelines of the WHO Good Manufacturing Practices (GMP).

Manufacturers that wish to receive technical assistance from USP DQI in this endeavor may submit their Expression of Interest to the WHO Prequalification team on the following products:

• Capreomycin 1 g powder for injection, vial
• Cycloserine 250 mg capsule
• Kanamycin 1 g powder for injection, vial
• Levofloxacin 250 mg tablet
• Moxifloxacin 400 mg tablet
• Para-Aminosalicylic Acid (PASER) 4 g granules
• Para-Aminosalicylic Sodium 60% 100 g granules

The GDF authorizes which manufacturers will receive technical assistance. For those companies, USP DQI will review the product dossier(s) for completeness, consistency, and credibility and will determine whether the information fulfills the WHO criteria. At this time, assistance is limited to manufacturers who contact USP DQI between October 1, 2008 and September 20, 2009. .

Working with USP DQI does not guarantee WHO prequalification status; it offers manufacturers the opportunity to initially present a stronger, higher-quality dossier. Whether assessing preliminary dossiers, conducting GMP inspections, or testing samples for quality, USP DQI will provide the necessary resources to complement the WHO prequalification program. Contact for more information.

If you are interested in receiving technical assistance on dossier preparation and the GMP onsite audit, download and complete the Pharmaceutical Product Questionnaire from the GDF website. Upload a copy of your completed questionnaire with your request for assistance and save a copy for your records.
All information will remain confidential.

USP DQI Assistance Request Form