WHO PQ Program: Summary

[Guest guest]

Hello Everybody,

Last week we discussed a relatively new topic “WHO Prequalification

Programâ€. The Prequalification(PQ) Programme was set up in 2001 by WHO to

facilitate access to medicines (for HIV, AIDS, malaria and tuberculosis and

later for reproductive health) that meet unified standards of quality, safety,

and efficacy. From the outset, the project has been supported by the Joint

United Nations Programme on HIV/AIDS (UNAIDS), the United Nations Children's

Fund (UNICEF), the United Nations Population Fund (UNFPA), and the World Bank to

contribute to the United Nations (UN) priority goal of addressing widespread

diseases in countries with limited access to quality medicines.

The list of prequalified products is used primarily by UN agencies to guide

their procurement decisions. However, the list has become a vital tool for any

agency or organization involved in bulk purchasing of medicines at the country

or global level.

HOW IT WORKS?

Manufacturers wishing their medicines to be included in the

prequalified products list are invited to apply. The manufacturer provides a

comprehensive set of data about the quality, safety and efficacy of its product,

including details about the purity of all ingredients used in manufacture, data

about finished products, such as information about stability, and the results of

in vivo bioequivalence tests.

The team of assessors evaluates all the data presented and if satisfied

with the evidence sends the product to professional quality control laboratories

contracted by WHO for analytical verification of quality.

If the product is found to meet the specified requirements, WHO sends

an inspection team to the manufacturing site which assesses working procedures

for compliance with WHO Good Manufacturing Practices (GMP). If the

manufacturing site complies with GMP, both the product linked to this

manufacturing site and company are added to a list hosted by WHO on a public web

site. Alternatively, the inspections carried out by stringent regulatory bodies

are recognized and their work is not duplicated by WHO (Alternative listing

procedures).

All product and manufacturing site requirements, standards used in

evaluating the product and the profile of the inspection teams are outlined on

the WHO prequalification project web site. The site also includes the list of

prequalified medicines and their manufacturers.

The assessment teams evaluating the products and manufacturers include

experts from some of the national regulatory authorities of the European Union

as well as Canada and Switzerland. These teams ensure that high quality,

international standards are respected. The teams work with regulators from the

developing countries where the medicines will be used to make sure that the

process and results are at all times transparent and trusted by the end-users.

WHO also accepts requests from member countries for taking DRA/ FDA inspectors

for free training and upgrading their skills for conducting the inspections.

The PQ process takes a minimum of three months if the product meets all

the required standards. When products do not meet the appropriate standards the

process can be longer and if the manufacturer fails to prove the quality, safety

and efficacy of its medicine it will not be prequalified.

Inclusion in the list does not mean that the prequalified status of a

product lasts forever. All medicines are requalified after three years, or

earlier, if needed. WHO also carries out random quality control testing of

prequalified medicines that have been supplied to countries.

As a part of its PQ program WHO also undertakes PQ of QC Laboratories

with the aim to increase the access to QC Laboratories that meet recommended

standards for testing of medicines(GLPs) and are committed to provide a service

of testing of medicinal products to UN agencies. This procedure was established

in 2004 in cooperation with UNICEF,UNFPA,UNAIDS,UNITAID and with the support of

the World Bank.

WHO assists countries in building national regulatory capacity through

networking, training and information sharing. These activities have been

endorsed and supported by Member States through numerous World Health Assembly

resolutions.

The PQ project is part of these activities and mandate. It does not intend

to replace national regulatory authorities or national authorization systems for

importation of medicines.

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Contribution from Dr. Ishaq Geer is worth mentioning and is highly appreciated.

Thanks are also due to Anupama, Madam Kunda and Thawani Sir for their valuable

posts.

Thank You all.

Dr. Smita Sontakke

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