The Laboratory Services Department is the technical department of Rwanda FDA responsible for providing independent, reliable, and scientifically sound laboratory services to support the regulation of regulated products. The Department conducts quality control testing, laboratory investigations, and lot release activities using internationally recognized standards and validated analytical methods. Through the implementation of a robust Quality Management System in accordance with ISO/IEC 17025 and other applicable regulatory requirements, the Department generates credible scientific evidence that supports regulatory decision-making, safeguards public health, and promotes confidence in products placed on the market.

These roles and responsibilities are implemented through the following Divisions and Units within the Laboratory Services Department:

1. Drugs Testing Division

2. Vaccines and Biologics Testing Division
3. Food Testing Unit
4. Microbiology Unit
5. Pesticides, Poisonous Substances and Chemical Testing Unit

6. Medical Devices and Instrumentation Testing Unit

    

Drugs Testing Division

The Drug Testing Division is responsible for:

1. Conducting physicochemical testing of medicines and cosmetics to determine compliance with approved quality standards.

2. Developing, verifying, validating and implementing analytical methods and standard testing procedures.

3. Ensuring the integrity, confidentiality and timely reporting of laboratory test results.

4. Implementing and maintaining the laboratory Quality Management System in compliance with ISO/IEC 17025 and applicable regulatory requirements.

5. Supporting regulatory decision-making through scientific testing, technical advice and laboratory investigations.

    

 Vaccines and Biologics Testing Division

Vaccines and Biologics Testing Division is responsible for:

1. Conducting quality control testing and lot release of vaccines and biological products.

2. Reviewing manufacturers' lot documentation and perform technical assessment for regulatory release.

3. Developing, validating and implementing analytical methods and standard testing procedures for biological products.

4. Ensuring compliance with laboratory quality management requirements and international standards.

5. Providing scientific evidence to support regulatory decisions on vaccines and biological products.

Food Testing Unit

 The Food Testing Unit is responsible for:

1. Conducting chemical and physical testing of processed foods and food supplements for compliance with established standards.

2. Developing, verifying and implementing validated analytical methods and standard testing procedures.

3. Ensuring accurate, reliable and timely reporting of laboratory test results.

4. Participating in laboratory quality assurance activities, including proficiency testing and equipment qualification.

5. Supporting food safety regulatory decisions through scientific laboratory analysis.

Microbiology Unit

The Microbiology Unit is responsible for:

1. Performing microbiological testing of regulated products, environmental samples and related materials.

2. Detecting microbial contamination and evaluate compliance with microbiological quality standards.

3. Developing, validating and implementing microbiological test methods and standard procedures.

4. Maintaining microbiological quality assurance, biosafety and data integrity requirements.

5. Providing microbiological evidence to support regulatory actions and public health protection.

Pesticides, Poisonous Substances and Chemical Testing Unit

The Pesticides, Poisonous Substances and Chemical Testing unit is responsible for:

1. Conducting quality and safety testing of pesticides, household chemicals, poisonous substances and other regulated chemicals.

2. Developing and implementing validated analytical methods and standard testing procedures.

3. Ensuring accurate, reliable and timely laboratory reporting to support regulatory decisions.

4. Maintaining compliance with laboratory quality management, equipment calibration and proficiency testing requirements.

5. Providing technical expertise on the quality, safety and compliance of regulated chemical products.

Medical Devices and Instrumentation Testing Unit

 The Medical Devices and Instrumentation Testing Unit is responsible for:

1. Conducting laboratory testing of medical devices including in vitro diagnostics and related products against applicable technical standards.

2. Developing, verifying and implementing testing methods and standard testing procedures for medical devices.

3. Ensuring the accuracy, reliability and traceability of testing results.

4. Maintaining laboratory quality management practices, equipment qualification and technical competence.

5. Providing scientific evidence to support regulatory evaluation, conformity assessment and market surveillance of medical devices.