World Health Organization Prequalifies Central Asia’s First Medicines Quality Control Laboratory

Kazakhstan labWith support from the U.S. Agency for International Development (USAID)’s Promoting the Quality of Medicines (PQM) program, Kazakhstan now has the first World Health Organization (WHO) prequalified medicines quality control laboratory in Central Asia, positioning the country to better assure the quality of tuberculosis (TB) and other medical products in the country and region.

TB kills more people every year than any other infectious disease, including HIV and AIDS, with an estimated 1.5 million dying in 2018. To end this global epidemic, a reliable supply of effective, quality-assured TB treatments is critical. But in many countries, poor quality and substandard anti-TB medical products are still available, contributing to increasing morbidity and mortality as well as drug resistance. Kazakhstan is among the highest multi-drug resistant tuberculosis (MDR-TB) burden countries in the world. Twenty-seven percent of Kazakhstan’s new TB cases and 64 percent of previously treated cases had MDR-TB or rifampicin-resistant TB. Rifampicin is an important first-line TB medical product.

One of the contributing factors to resistance could be the quality of the medical products. In Kazakhstan, most anti-TB medical products are procured locally, often from sources that have not met WHO prequalification standards, an internationally recognized benchmark for quality which also helps to confirm a laboratory’s ability to reliably and accurately assess medicine quality. A study published in 2014, for example, found that 19 percent of the TB medical products sampled in Almaty City failed at least one test for quality.

The Government of Kazakhstan allocates significant resources and works closely with international partners to fight TB in the country. This includes all aspects of TB control, including the strengthening of its medical product quality assurance system. Reliable testing of quality of medical products is a cornerstone of a good quality assurance system. PQM worked closely with Kazakhstan’s national medicines regulatory authority, the National Centre for Expertise of Medicines, Medical Devices, and Medical Equipment (NCEM) to support three regional quality control laboratories to strengthen their quality management systems and capacity to comply with WHO prequalification standards.

PQM, which was implemented by U.S. Pharmacopeia (USP) collaborated with the medicines quality control laboratories (MQCLs) to build their capacity to accurately and reliably test the quality of anti-TB and other essential medical products. The program used a collaborative learning model whereby three laboratories shared and standardized lessons and best practices and conducted audits leading to corrective actions, building a solid foundation for sustainable mutual support.

In January 2020, WHO recognized Karaganda’s NCEM as being in compliance with the standards of WHO Good Practices for Pharmaceutical Quality and Control Laboratories. The NCEM is the first WHO-prequalified laboratory in Central Asia. Two additional laboratories in Nur-Sultan and Almaty will shortly be ready for WHO prequalification. Support from three regional laboratories prequalified by WHO will help the Government of Kazakhstan to reduce the availability of substandard medicines, contributing to the fight against TB.

The follow-on PQM+ program, which is also led by USP, continues to support these laboratories in terms of strengthening their quality management system and achieving WHO prequalification. In addition, PQM+ works with the Karaganda laboratory to ensure the sustainability of their quality standards and to share its experience and best practices with other medicines quality control laboratories in Kazakhstan and Uzbekistan.