September 4, 2005

The materials in this section were prepared under the direction of Ms. Margareth Ndomondo- Sigonda, Director-General of the Tanzania Food and Drugs Authority (TFDA), with technical and financial support from Management Sciences for Health (MSH), funded by the Bill & Melinda Gates Foundation’s Strategies for Enhancing Access to Medicines (SEAM) Program.

This program has been described in part at: http://www.msh.org/seam/conference2005/poster.html#9_TZ_QA

Included in this section are the Drug Inspection Flow-Chart, Level One Drug Inspector’s Handbook, Training Facilitation Guide, and the inspection forms used to guide and conclude the inspection processes. The Inspectors’ Manual is formatted and paginated for two-side page printing.

To initiate this effort, the laws and regulations of the Tanzania Revenue Authority and the TFDA pertaining to drugs first were codified into a flow chart which included decision points on compliance to standards and guidance to inspectors. That flow-chart was then used to develop Standard-Operating-Procedures (SOPs) to guide the inspectors through the inspection process.

These SOPs and associated materials were compiled into the Level One Drug Inspectors’ Handbook. Forms were then developed to discipline and track the inspection process. The Inspection Forms have been programmed in “Pendragon” software for use on a Personal Digital Assistant (PDA). The Pendragon software is compatible with Microsoft Access so the PDAs can be downloaded into Access. In addition the TFDA database of authorized drug products-authorized manufacturer-authorized source country can be loaded into look-up tables on the PDA so those elements on the forms can be menu-selected for entry into the forms. The TFDA data bases of approved Part I shops (prescription retail stores), registered pharmacists, and registered dispensaries also are loaded on the PDAs for menu-select fill-ins. Items or persons not in the data bases are not registered. The PDA forms also have mandatory fill-ins to discipline and guide the inspection process. The PDA effort has been described at: http://www.msh.org/seam/conference2005/pdf/Poster/45_CI4_QA.pdf

Currently available Inspection forms:

Sample Receipt Form.pdf
Rejection-Detention Form.pdf
POE Screening Certificate.pdf
Facility Screening Certificate.pdf
Confiscation-Quarantine Form.pdf

TFDAINS 001 Port of Entry Consignment Inspection Form.pdf
TFDAINS 002 Port of Entry Product Physical Examination Form.pdf
TFDAINS 003 Facility Product Physical Examination Form.pdf
TFDAINS 004 Part 1 Shop Inspection Form-Retail Prescription Pharmacy.pdf
TFDAINS 005 Abbrev Part 1 Inspection Form.pdf
TFDAINS 006 Dispensary Inspection Form.pdf
TFDAINS 007 Abbrev Dispensary Inspection Form.pdf
TFDAINS 008 Part II Outlet Inspection Form-Baridi-Muhimu.pdf
TFDAINS 009 Abbrev Part II Inspection Form.pdf

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