Regulation and Prequalification
Progress towards enhancing regulatory practices related to medical products around the world is supported by capacity building, promoting regulatory convergence and harmonization.

The world of laboratories is ever changing, with new and innovative technologies coming on board, updated requirements for facilities and quality management systems.  As quality control laboratories produce data that contribute to the final decision making, whether or not a particular health product will obtain regulatory approval and market access, it is obvious that their performance needs to meet international acceptable standards.

In this regard, LNS contributes to the development of the essential performance evaluation framework of laboratories for Benchmarking and the competency framework for laboratory analysts.

  • Specific technical assistance is provided to laboratories based on the findings of the on-site audits by WHO LNS and Inspectorate / Experts and/or peer audits.
  • Webinars and hands on trainings on specific quality testing methods
  • Training through twinning with expert laboratories on various topics

                >  innovative test protocols

                >  maintenance of equipment

  • Webinars and hands on trainings on specific quality testing methods are conducted to harmonize testing protocols and make data more comparable.
  • Support is also provided post training to facilitate the implementation of newly acquired skills in the laboratories of the trainees.
  • Proficiency studies are set up to monitor the performance of the laboratories and identify any potential issues that require further attention and corrective actions.

More information:

https://extranet.who.int/prequal/content/technical-assistance

Quality testing of vaccines. WHO Drug Information Vol. 30, No. 2, 2016:176-179:

Supporting countries in Quality Assurance for Pentavalent vaccines:

Determination of total and free saccharide content in liquid formulations: a challenge for laboratories and manufacturers:

Vaccine control – Feasibility of a serological potency assay for rabies vaccines for human use. WHO Drug Information Vol. 31, No. 1, 2017:27-29 

 

 

WHO National Control Laboratory Network for Biologicals (WHO-NNB)

Information (text) to be developed further

WHO, Collaboration – Global network of national vaccine control laboratories. WHO Drug Information, 2017. 31(1): p. 3-10:

WHO, Regulatory networks - Update on the WHO-National Control Laboratory Network for Biologicals, WHO Drug Information, 2018. 32(2): p. 189-193.