Laboratory Services Department

The LSD is a technical regulatory department in the Rwanda Food and Drugs Authority whose mandate is to establish the quality control of regulated products, including analyzing different categories of processed food products, drugs, medical devices, vaccines, biologics and other public health products to ensure product compliance with the set standards and enable the Authority to make evidence-based regulatory decisions. The LSD serves also for research, training and education purposes. 

The Laboratory Services Department operates under two Divisions and four Units:

  • Drugs Testing Division

This division is in charge of testing medicines and cosmetics. Its role and responsibilities include:

  • Analyzing medicines and cosmetics, ensuring the product’s compliance with standard specifications and timely reporting test results
  • Ensuring that all medicines and cosmetics are correctly tested for quality, safety, and efficacy to enable Rwanda FDA to make evidence-based regulatory decisions
  • Implementing the quality management system of the institution
  • Planning and participation in laboratory Proficiency Testing (PT)
  • Developing standard operating procedures for medicines and cosmetics testing
  • Performing test methods development, verification, validation, and estimation of uncertainty
  • Ensuring that test data within the laboratory are secured and confidentially kept
  • Ensuring compliance with international standards within the division
  • Providing support in training, education and research within the division
  • Ensuring the maintenance and calibration of testing equipment
  • Providing quality services that meet customer regulatory requirements and Rwanda FDA quality objectives
  • Collaborating with other regulatory functions and their stakeholders to implement Rwanda FDA mission, goals, and strategic objectives
  • Ensuring that national, regional, and international regulations, guidelines, manuals, SOPs, STPs, protocols, and other quality management documents for drugs & cosmetics are properly implemented.
  • Vaccines & Biologics Testing Division

This division is in charge of lot release including testing of vaccines and other biologics and timely issuance of regulatory documents. Its role and responsibilities include:

  • Coordinating and conducting the testing of Vaccines and other Biologics and ensuring timely reporting of test results
  • Implementing the quality management system of the institution
  • Ensuring that all Vaccines and Biologics are correctly tested for quality, safety, and efficacy to enable Rwanda FDA to make evidence-based regulatory decisions
  • Reviewing Vaccines & Biologics lot summary protocols from manufacturers applying for marketing authorization
  • Preparing standard testing procedures (STPs) for testing of Vaccines and Biologics
  • Collaborating with other regulatory functions and their stakeholders to implement Rwanda FDA mission, goals, and strategic objectives
  • Ensuring that national, regional, and international regulations, guidelines, manuals, SOPs, STPs, protocols, and other quality management documents for Vaccines & Biologics are properly implemented.
  • Food Testing Unit

This unit is in charge of testing food products. Its role and responsibilities include:

  • Analyzing processed foods including food supplements and ensure

the product’s compliance with standard specifications and timely reporting of test results

  • Ensuring that all processed foods are correctly tested for quality, safety, and efficacy to enable Rwanda FDA to make evidence-based regulatory decisions
  • Implementing the quality management system of the institution
  • Planning and participation in laboratory Proficiency Testing (PT)
  • Developing standard operating procedures for processed food testing
  • Performing test methods development, verification, validation, and estimation of uncertainty
  • Ensuring that test data within the laboratory are secured and confidentially kept
  • Ensuring compliance with international standards within the unit
  • Providing support in training, education and research within the unit
  • Ensuring the maintenance and calibration of testing equipment
  • Providing quality services that meet customer regulatory requirements and Rwanda FDA quality objectives
  • Collaborating with other regulatory functions and their stakeholders to implement Rwanda FDA mission, goals, and strategic objectives
  • Ensuring that national, regional, and international regulations, guidelines, manuals, SOPs, STPs, protocols, and other quality management documents for processed foods products are properly implemented.
  • Microbiology Unit

This unit is in charge of testing medicines, cosmetics, food products and medical devices. Its role and responsibilities include:

  • Analyzing medicines, cosmetics, food products and medical devices and ensuring the product’s compliance with standard specifications and timely reporting test results
  • Ensuring that all medicines, cosmetics, food products and medical devices are correctly tested for quality, safety, and efficacy to enable Rwanda FDA to make evidence-based regulatory decisions
  • Implementing the quality management system of the institution
  • Planning and participation in laboratory Proficiency Testing (PT)
  • Developing standard operating procedures for microbiology testing of medicines, cosmetics, food products and medical devices
  • Performing test methods development, verification, validation, and estimation of uncertainty
  • Ensuring that test data within the laboratory are secured and confidentially kept
  • Ensuring compliance with international standards within the unit
  • Providing support in training, education and research within the unit
  • Ensuring the maintenance and calibration of testing equipment
  • Providing quality services that meet customer regulatory requirements and Rwanda FDA quality objectives
  • Collaborating with other regulatory functions and their stakeholders to implement Rwanda FDA mission, goals, and strategic objectives
  • Ensuring that national, regional, and international regulations, guidelines, manuals, SOPs, STPs, protocols, and other quality management documents for medicines, cosmetics, food products and medical devices are properly implemented.
  • Pesticides & Poisonous Substances and Chemical Testing Unit

This unit is in charge of testing household chemicals, pesticides & poison substances and other Chemicals. Its role and responsibilities include:

  • Analyzing household chemicals, pesticides & poison substances and other chemicals and ensuring the product’s compliance with standard specifications and timely reporting test results
  • Ensuring that all household chemicals, pesticides & poisons substances and other chemicals are correctly tested for quality, safety, and efficacy to enable Rwanda FDA to make evidence-based regulatory decisions
  • Implementing the quality management system of the institution
  • Planning and participation in laboratory Proficiency Testing (PT)
  • Developing standard operating procedures for household chemicals, pesticides & poison substances and other chemicals testing
  • Performing test methods development, verification, validation, and estimation of uncertainty
  • Ensuring that test data within the laboratory are secured and confidentially kept
  • Ensuring compliance with international standards within the unit
  • Providing support in training, education and research within the unit
  • Ensuring the maintenance and calibration of testing equipment
  • Preparing technical specifications for new equipment and reagents required for testing of household chemicals, pesticides & poisons substances and other chemicals
  • Providing quality services that meet customer regulatory requirements and Rwanda FDA quality objectives
  • Collaborating with other regulatory functions and their stakeholders to implement Rwanda FDA mission, goals, and strategic objectives
  • Ensuring that national, regional, and international regulations, guidelines, manuals, SOPs, STPs, protocols, and other quality management documents for household chemicals, Pesticides & Poisons Substances and other Chemicals are properly implemented.

Devices & Instrumentation Testing Unit

This unit is in charge of testing medical devices including but not limited to condoms, gloves, needles, syringes, bandages and facemasks.  Its role and responsibilities include:

  • Analyzing medical devices and ensuring the product’s compliance with standard specifications and timely reporting test results
  • Ensuring that all medical devices are correctly tested for quality, safety, and efficacy to enable Rwanda FDA to make evidence-based regulatory decisions
  • Implementing the quality management system of the institution
  • Planning and participation in laboratory Proficiency Testing (PT)
  • Developing standard operating procedures for medical device testing
  • Performing test methods development, verification, validation, and estimation of uncertainty
  • Ensuring that test data within the laboratory are secured and confidentially kept
  • Ensuring compliance with international standards within the unit
  • Providing support in training, education and research within the unit
  • Ensuring the maintenance and calibration of testing equipment
  • Providing quality services that meet customer regulatory requirements and Rwanda FDA quality objectives
  • Collaborating with other regulatory functions and their stakeholders to implement Rwanda FDA mission, goals, and strategic objectives
  • Ensuring that national, regional, and international regulations, guidelines, manuals, SOPs, STPs, protocols, and other quality management documents for medical devices are properly implemented.