Dr. Danstan Hipolite Shewiyo.
Director, Laboratory services
TMDA Quality Control Laboratory is established under section 14(1) of the Tanzania Medicines and Medical Devices Act, Cap. 219, to carry out analysis of regulated products.
TMDA has three laboratories in Dar es Salaam, Mwanza and Dodoma. The laboratories are located at TMDA sub-Head office and Zonal offices in Dodoma and Mwanza. These laboratories are complemented by 25 medicines quality assurance centers which are equipped with minilab kits. The centers are stationed at ports of entries, zone offices and some regional referral hospitals across the country.
Test results generated enable the Authority to make evidence-based regulatory decisions.
The laboratory is mandated to perform the following functions:
- Analysis of medicines, medical devices,diagnostics and tobacco products;
- Conducts research and training in the scope of regulated products.
TMDA top management is committed to complying with the requirements of the ISO/IEC 17025:2017 and WHO Good Practices for Pharmaceutical Quality Control Laboratories and ensures that laboratory services rendered to its customers are always offered by competent laboratory personnel in an impartial manner. Management provides resources for implementation and continually improves effectiveness of our Quality Management System by ensuring that personnel within the Laboratory are familiar with the quality documentation and implement consistently policies and procedures in their work.
The laboratory is prequalified since January 2011 after assessment and compliance to WHO requirements and is therefore among the fifty-seven (57) prequalified quality control laboratories (List of WHO prequalified laboratories by June, 2021).
Some benefits attained from prequalification are
- International recognition
- Increased customer confidence
- Demonstration of competence
- Produce accurate and reliable results
- Increased revenue
The laboratory serves both internal and external customers. Some of the key customers include;
- Government institutions and Ministries;
- Product manufacturers;
- Importers and distributors;
- Exporters;
- Researchers;
- Wholesalers and retailers; and
- International organizations (e.g WHO).
Analysis of samples
The laboratory performs analysis of medicines, medical devices, In-vitro diagnostics, tobacco products and non-regulated products.
The Quality Control testing is performed against national and international standards such as Pharmacopoeias, ISO standards, etc. Testing results are released within a period stipulated in the Customer Client Service Charter.
For more information about analysis of regulated and non-regulated products click here.
Process flow
Training
Various training on laboratory operations and systems are provided to interested customers. Training is conducted at a fee and could be in the form of attachments, short courses, tours, internships, and field work.
Trainings offered are as follows;
- Training on Quality Management System – ISO/IEC 17025 (Competence of Testing and Calibration Laboratories)
- Training on laboratory analytical techniques
- Training on analytical method development and validation
- Training on microbiological testing
- Training on Good Clinical and Laboratory Practices
- Training on Quality Management System – ISO 15189 (Medical Laboratories requirements for quality and competence)
Consultancy services
Consultancy services is provided in all areas of laboratory operations and quality management system.
For more information about fees and charges on our services please click here
The laboratory has established Quality assurance centers that aim to screen consignments of selected group of medicines at ports of entries before entering the country as well at centers within the country to screen medicines already in the market.
This facilitates monitoring quality of registered medicines products to safeguard public health. These centers are equipped with GPHF-Minilab kit for detecting falsified and substandard medicine products.
GPHF is a simple and relatively easy and quick technique for quality screening of medicinal products in the field. The kit is capable of carrying out visual inspection, disintegration tests for oral solid dosage forms and thin-layer chromatography (TLC) for identification of active pharmaceutical ingredients (APIs) present in a formulation.
TMDA has placed minilab kits in 25 quality assurance centers in the country which are located at ports of entries, regional referral hospitals (RRH) and TMDA zone offices.
| Location | No. | Quality Assurance Center |
| LAKE ZONE | 1 | Geita Region Referral Hospital |
| 2 | Bukoba Region Referral Hospital | |
| 3 | Musoma Region Referral Hospital | |
| 4 | Mtukula (port of entry) | |
| 5 | Sirari (port of entry) | |
| 6 | TMDA Eastern Lake Zone office | |
| NOTHERN ZONE | 1 | Manyara Region Referral Hospital |
| 2 | Kilimanjaro Region Referral Hospital | |
| 3 | Kilimanjaro International Airport (port of entry) | |
| 4 | Namanga (port of entry) | |
| 5 | TMDA Nothern Zone office | |
| SOUTHERN HIGHLAND ZONE | 1 | Mbeya Region Referral Hospital |
| 2 | Tunduma Region Referral Hospital | |
| 3 | Sumbawanga Region Referral Hospital | |
| 4 | Iringa Region Referral Hospital | |
| EASTERN ZONE | 1 | Horohoro (port of entry) |
| 2 | Bombo Region Referral Hospital | |
| 3 | TMDA Eastern Zone office | |
| SOUTHERN ZONE | 1 | Lindi Region Referral Hospital |
| 2 | Mtwara Region Referral Hospital | |
| 3 | Songea Region Referral Hospital | |
| CENTRAL ZONE | 1 | TMDA Central Zone office |
| WESTERN ZONE | 1 | Tabora Region Referral Hospital |
| 2 | Kigoma Region Referral Hospital | |
| 3 | Katavi Region Referral Hospital |