The main TMDA Quality Control Laboratory at the sub-head office in Dar es Salaam is subdivided into three (3) sections: Medicines Chemical Analysis, Microbiology Analysis, and Medical Devices and Diagnostics Testing.
The laboratory is responsible for testing medicines, raw materials for medicines, diagnostics, and medical device products.
The Medicines Chemical Analysis Laboratory has been prequalified by WHO for the testing of medicines since January 2011. The Microbiology Analysis Laboratory was prequalified for pharmaceutical testing in November 2021. Plans to accredit the Medical Devices and Diagnostics Testing Laboratory is accredited based on ISO/IEC 17025:2017 since 2024.
Laboratory Quality Management System
The Laboratory Quality Management System office is located in the office of the laboratory Director, and is handled by Laboratory Quality Officer (LQO). It oversees the implementation of Quality Management System in accordance with the requirements of ISO/IEC 17025:2017 and WHO - Good Practices for Pharmaceutical Quality Control Laboratory and other recommended standards.
The management ensure that laboratory staff are free from undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of the work.
The laboratory is equipped with ultra-modern instruments that are calibrated and maintained at frequencies specified by QMS documents in order to ensure maximum run-time and produce reliable and accurate results.
Laboratory Personnel
Qualified and competent staff are employed and subjected to regular training as per approved training programme and proficiency testing scheme for competence assessment. Dar es Salaam TMDA Quality Control Laboratory has 43 staff with various qualifications as follows:
| PhD | 2 |
| Master’s degree | 10 |
| Bachelor degree | 16 |
| Diploma | 8 |
| Certificate | 7 |
