Laboratory analysis for quality, safety and effectiveness

 

Laboratory analysis are carried out to ascertain the quality, safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices manufactured or imported into Tanzania. The results obtained are usefulin decision-making

Tanzania Food, Drugs and cosmetics, Act No 1 of 2003 section 14 gives legal power to TFDA laboratory.

Functions of the laboratory

1. To analyse drugs, medical devices, herbal drugs, cosmetics, raw materials, drug adjuvant, packaging materials, drug delivery systems, systemic diagnostic agents and any other product that may be deemed to constitute a drug or cosmetic product

2. To Analyse food, food packaging, materials and raw materials used in the manufacture of food

3. To develop methods of analysis of products regulated by the authority.

4. To train and offer consultations to learning institutions, individuals, firms and any other organization who perform activities related to quality control of products regulated by the Authority.

5. To coordinate the activities of small mobile mini-Laboratories stationed at major ports of entries and in some regional hospitals. These Laboratories are particularly stationed at Dar es Salaam Harbours, and in the following Regional Hospitals Arusha, Mtwara, Musoma, Dodoma, and Mbeya.

Organization of the Directorate

The directorate comprises of five departments which   collectively are the food analysis, microbiology, medicines and Cosmetics Analysis, medical devices testing and technical support department. The functions performed by each department are elaborated below:-

Food Analysis

This department deals with food analysis of all food samples submitted to the     Laboratory, for qualitative and quantitative tests.  Specifically the following are done:

1. Analyse food products for complience with standards

2. Develop analytical methods
3. Prepare food laboratory guidelines, manual and Standard Operationg Procedure (SOPs)
4. Participate in the preparation of food standards.

Medicines and cosmetics Analysis Department

Microbiology Deparment

This deparment deals with microbial analysis of all samples submitted to the laboratory that  require these tests.  The aim of microbial analysis is to ensure absence of harmful microbes and presence of required number of non-harmful microbes in product samples that are not sterile.  The specific activities of this section are as follows:-

1. Microbial limit test: To detect amount of non harmful microbes in a product sample as per the specified monographs standards.                                         

2. Sterility test: To determine absence of micro organisms and their toxins in various sterile samples e.g. injectables, eye preparations etc,

3. Microbial contamination test: To determine the absence of harmful/pathogenic micro organisms in product samples. 

4. Preservative challenge test: To determine the effectiveness of preservatives in product sample

5. Bioassay: Quantitative determination of active ingredients in various product samples brought to the Laboratory.

Medical Devices Testing

This department deals with test of medical devices.  The     specific activities of this department includes:-

1. Test medical devices .

2. Prepare laboratory guidelines, manual and standard Operationg Procedures.

3. Develop testing methods and technology .

4. Maitain testing equipment.

Technical Support and Research

This department ensures that all equipment and instruments are in good condition and fully functioning. It also deals with development and validation of various analytical methods and development of guidelines, manuals and standard operating procedures for the TFDA Laboratory. This deparment is reponsible for coordinating implementation of laboratory quality system. Also the department is conduct and coordinate research.

Medicinces and cosmetics Analysis Department

This department deals with drugs and cosmetics analysis of all samples submitted to the     Laboratory, for qualitative and quantitative tests.  Specifically the following are done: The other function is verification of performance of drugs, cosmetics, and medical devices as      claimed by   manufacturers and specified in official monographs or any other acceptable methods.

The main functions of this department are:-

1. To analysis medicines and cosmetics for complience with standards

2. Prepare laboratory guidelines, manuals and standard Operation procedures

3. Develop analytical methods an preparation of specifications for medicines and cosmetics.

4. Maintain anlystical equipment.

Sources of samples analysed by the TFDA Laboratory

Pre-registration samples from product evaluation and registration departments

Post-marketing surveillance samples from Directorate of Food Safety and Directorate of Medicines and Cosmetics

Samples from external customers including manufactures, importers, wholesalers and retailers