Prequalification of Quality Control Laboratories

In the purpose of increasing access to quality control laboratories that meet recommended international norms and standards for the analysis of products in the Prequalification Programme HIV/AIDS, malaria and tuberculosis products, WHO, in collaboration with UNAIDS, UNICEF, UNFPA with the support of the World Bank started in 2004 the Programme of prequalification of quality control laboratories. In the first phase WHO invited Expressions of Interest from Quality Control Laboratories in Africa committed to providing a service of testing of pharmaceutical products, including but not limited to HIV/AIDS, Tuberculosis and Malaria products at affordable prices, to UN agencies.

Participation in the prequalification procedure is voluntary and currently the 3rd invitation has been published which is not limited to quality control laboratories from a specific region, however, WHO reserves the right to prioritize the assessment of national quality control laboratories or those laboratories which provide testing services to the government in the respective country, and quality control laboratories in areas where UN agencies identify the need for quality testing. The Prequalification of Quality Control Laboratories procedure relates to chemical and microbiological testing (including bacterial endotoxins test) of medicines.  It does not relate to medical devices, cosmetics or food, as well as immunological, pharmacological and toxicological tests.

• Quality Control Laboratories - 3rd Invitation for EOI [pdf]

Information for Applicants

• Procedure for prequalification

  • Procédure de préqualification

• Guidelines:

  • Laboratory Information File (LIF)

    • Directives pour la préparation d'un dossier d'information par le laboratoire

  • Good practices for pharmaceutical quality control laboratories

    • Régles de bonne pratique applicables par les laboratoires de contrôle qualité pharmaceutique

    • Buenas prácticas de la OMS para laboratorios de control de calidad de productos farmacéuticos

    • Boas práticas da OMS para laboratórios de controle de qualidade de produtos farmacêuticos

    • หลักปฏิบัติที่ดีสำหรับห้องปฏิบัติการควบคุมคุณภาพเภสัชภัณฑ์ขององค์การอนามัยโลก

       

  • Good practices for pharmaceutical microbiology laboratories [pdf]

  • Good Manufacturing Practices as recommended by WHO for such laboratories, together with its guidelines such as:

    • Transfer of technology in pharmaceutical manufacturing (including analytical method transfer)

    • Validation

    • Sterile pharmaceutical products

    • Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms

    • Water for pharmaceutical use

  • Model certificate of analysis

  • General guidelines for the establishment, maintenance and distribution of chemical reference substances

  • Guide to good storage practices for pharmaceuticals

  • Guidelines for sampling of pharmaceutical products and related materials

  • Considerations for requesting analyses of drug samples

The procedure established by WHO for assessment of quality control laboratories which expressed their interest includes the evaluation of the information submitted by a laboratory and an on site inspection of a laboratory to assess the compliance with the guidelines. If assessment demonstrates that a laboratory meets WHO recommended standards, it is included in the WHO List of Prequalified Quality Control Laboratories that are considered to be acceptable for use by United Nations agencies as well as the others.

Once a laboratory is included in the WHO List of Prequalified Quality Control Laboratories, ongoing monitoring of its activities will be performed including re-inspections at regular intervals (at least once every three years), evaluation of results from participation in an appropriate proficiency testing scheme, and monitoring and investigation of complaints concerning the results of analysis or service provided by the listed laboratories. To facilitate the monitoring each prequalified laboratory is requested to submit a brief annual report on its activities related to quality control of medicines within a calendar year, which should be submitted by the end of March of the following year.

WHO may suspend or withdraw a prequalified quality control laboratory from the List of Prequalified Quality Control Laboratories when there is evidence of non-compliance with the WHO recommended quality standards for such laboratories and/or this procedure.

Contact for Enquiries

       email:  prequallaboratories@who.int

Related links

Inspections of Quality Control Laboratories

• WHOPIRs

Quality Control Training, Seminars and Workshops

• Training modules

• Training seminars and workshops

Quality assurance of medicines

• Quality assurance

The International Pharmacopoeia (Ph.Int.)

• International Pharmacopoeia

• International Pharmacopoeia on-line

• Monograph development

International Chemical Reference Substances (ICRS)

• EDQM/WHO ICRS Collaboration