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In Tanzania, the collection and availability of correct and timely drug product inspectional and testing data are critical in drug regulation. By allowing staff in the field to monitor the flow of pharmaceuticals more efficiently, the larger governing body is able to identify and focus on trouble spots in the marketplace.

However, in order to do their work, field inspectors must have ready access to the country's drug marketing authorization database and must be able to efficiently collect and submit inspectional data.

The information from the country's database that is fed to the inspectors as they collect data includes a wide range of product-specific and site-specific information elements such as the following—

• a listing of approved products
• manufacturers
• importers

This knowledge allows the inspectors to cross check the products coming through the ports and local pharmacies, also known as Part II shops, and take appropriate action on any products or suppliers that are not currently registered in the country or are not allowed in the country.

Traditionally, this collected information has been handwritten by the inspectors on an inspection form. These paper inspection records are not only difficult to manage, but they must also be carefully and tediously entered into data files that can be used to summarize observations and prepare reports.

Because of a shortage of staff, the pace of data compilation has been greatly limited and the data collected has not been made available in a timely fashion for use in making important public health decisions.

Additionally, the Tanzania Food and Drugs Authority (TFDA) updates and revises this information frequently, but factors such as distance, cost, and maintenance prevent the updated data from being readily available to inspectors in the field.

A New System

As a way to rectify these problems, the TFDA, Management Sciences for Health (MSH), and SATELLIFE have adapted the existing inspection process to incorporate the use of PDAs by inspectors.

The ability of PDAs to store the most current lists of approved products, suppliers, and importers, as well as the most recent inspection forms, allows for instant transfer of data into the country’s database. Such maneuvering provides decision makers at the TFDA level with a complete and timely view of the situation across the country.

The continuing increase in PDA capability has made their use a financially and technically reasonable option for addressing data collection and information sharing needs.

Expected benefits of the fully implemented PDA program include the following—

• Tighter regulatory control of the marketplace
• Reduced error in data collection
• Greater availability of lists of approved products and marketers
• More timely access to needed information
• Decreased personnel costs

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