Quality Control Laboratory

Quality Control laboratory profile

The Quality Control Laboratory (QCL) is the standalone technical regulatory Division in Rwanda Food and Drugs Authority. The QCL mandate is to establish the quality assurance and quality control of regulated products including to analyze different categories of food and food products, medicines, medical devices and Public health products, from which samples are obtained from pre-market, post-shipment and Post-Market Surveillance in order to ensure products compliance with the set standards and enabling the Authority to make evidence-based regulatory decisions.

Medicines and Cosmetics Testing Unit

The Medicines and Cosmetics Unit is in charge of testing medicines, cosmetics, by ensuring timely analysis and preparation of scientific analytical reports.

The roles and responsibilities of the Medicines and Cosmetics Testing Unit are the following:

To conduct analysis of Medicines and Cosmetics and timely reporting of test results
To maintain laboratory quality management system of the unit
To elaborate the list of testing parameters and matrices for accreditation
To plan and participate in laboratory Proficiency Testing (PT) and evaluate PT results
To prepare procedures, test methods and standards operating procedures
To perform test methods development, methods validation and estimation of uncertainty budget
To ensure test data obtained from analytical work within the laboratory is secure and confidentiality is maintained

Pesticides & Poisonous Substances and Chemical Unit

Pesticides & Poisons Substances and Chemical Unit is in charge of testing of Pesticides & Poisons Substances and other Chemicals, and ensure timely analysis and preparation of scientific analytical reports.

The roles and responsibilities of the Pesticides & Poisons Substances and Chemical Unit are the following:

To conduct analysis of Pesticides & Poisons Substances and Chemical and timely reporting of test results.
To plan and review resources needed for implementation, maintenance and improvement of the laboratory QMS.
To elaborate the list of testing parameters and matrices for accreditation
To plan and perform laboratory Proficiency Testing (PT) and evaluate PT results
To prepare technical specifications for new equipment and reagents
To prepare procedures, test methods and standards operating procedures (SOPs)

Food Testing Unit

Food Testing Unit is in charge of testing and timely analysis of food products, and preparation of scientific analytical reports

The roles and responsibilities of the Food Testing Unit are the following:

To conduct analysis of food products and timely reporting of test results
To ensure proper storage of test samples, chemicals and reagents;
To prepare and standardize solutions, materials and reagents used in analysis;
To carry- out tests, interpreting results and estimating uncertainties of measurement
To participate in the development of new test methods, methods verification and validation
To ensure documentation of laboratory Standard Operating Procedures (SOPs) and submit them for approval;
To participate in quality control programs and prepare statistical report

Medical Devices & Instrumentation Unit

The Medical Devices & Instrumentation Unit is in charge of effective and efficient performance of medical devices, analysis and timely preparation for reporting of test results.

The Scope of testing covers nine (9) test parameters on male latex condoms namely:

Determination of Length
Determination of Width
Determination of Thickness
Determination of bursting volume and pressure
Testing for holes
Determination of Visible defects
Testing for Package seal integrity
Determination of total lubricants
Condom sampling

The Scope of testing gloves covers surgical and examination gloves for the following parameters namely:

Determination of Length
Determination of Width
Determination of Thickness
Testing for holes
Determination of Visible defects
Gloves sampling

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