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

Fields in bold are required.

First Name
Last Name
Title
Company

Contact Information

	Country
	Phone
	Hours
	Email

Product Description

Please choose the product type(s) that apply to your product or if Other, please specify.	Does the product have a dossier?
Capreomycin 1 g powder for injection vial	Yes No
Cycloserine 250 mg capsule	Yes No
Kanamycin 1 g powder for injection, vial	Yes No
Levofloxacin 250 mg tablet	Yes No
Moxifloxacin 400 mg tablet	Yes No
Para-Aminosalicylic Acid (PASER) 4 g granules	Yes No
Para-Aminosalicylic Sodium 60% 100 g granules	Yes No
Other Please specify:

GMP Status

Please choose the type of GMP status you may currently have or if Other, please specify.

WHO Country (local)

Other
Please specify:

Attach Questionnaire

Download and complete the Pharmaceutical Product Questionnaire from the GDF website.
Please attach your completed Questionnaire here, saving a copy for your records: