A National Lab’s Journey to Meeting WHO Standards

“A healthy population is key to a nation’s prosperity and wellbeing. As health specialists, our goal is to serve our country,” says Nadezhda Arhipova, Head of the Karaganda’s Medicines Quality Control Laboratory within an affiliate of the National Center of Expertise of Medicines and Medical Devices in Karaganda oblast. She is passionate about ensuring medicines produced in Kazakhstan are of a high quality so that fellow citizens have access to reliable and safe drugs. 

As a child, Nadezhda never imagined working in a pharmaceutical laboratory. After graduating from Karaganda University in 2001 with a degree in chemistry, she joined the Karaganda laboratory that manages the nation’s pharmaceuticals quality control. 

In 2019, twenty years into her career, the Karaganda laboratory, with support from the USAID Promoting the Quality of Medicines Plus activity, was prequalified by the World Health Organization (WHO). WHO prequalification is an internationally recognized quality assurance system that confirms a laboratory’s ability to reliably assess the quality of medicines.

Globally tuberculosis (TB) is a public health threat that kills more people every year than any other infectious disease. Kazakhstan is a high multi-drug resistant TB (MDR-TB) burden country which is a difficult public health issue as the people infected with MDR-TB require prolonged courses of treatment. Drug-resistant TB occurs when TB bacteria is resistant to the main first-line TB treatment. This can occur when patients interrupt their TB treatment regimen. Poor quality of drugs is one factor for patients to interrupt their treatment because their medication is not as effective as it should be. For this reason, it is critical for the national government to have a supply of reliable, effective, quality-assured drugs to treat TB effectively. 

To ensure high quality, reliable and safe medicines are available to TB patients in Kazakhstan, the Karaganda laboratory applied for WHO prequalification. “At that time, we were concerned since we weren’t sure how to undertake the process,” recalls Nadezhda. With assistance from USAID advisors, the Karaganda laboratory underwent a quality assessment. 

Nadezhda fondly recalls the enthusiasm that united the USAID advisors and Karaganda laboratory staff. Together, they walked through the facility, looked at lab protocols, and inspected lab equipment. “The process was a collaborative effort to develop a plan to meet with WHO standards. During those three days, I learned a lot and the advice we received was transformative.”

The assessment allowed Karaganda lab and USAID to draft a plan for the WHO application and to implement the assessment recommendations that positively impacted the operational efficiency to assess medicine quality. USAID continued technical assistance to the Karaganda lab to move towards WHO prequalification by revising quality manual and standard operation procedures to implement and remain compliant with the assessment recommendations. Today, the lab operates with updated methods and utilizes modern equipment.  

In 2019, the Karaganda lab underwent a long-awaited WHO audit and successfully received WHO prequalification. Nadezhda proudly recalls the significant milestone, “In 2020, the Karaganda laboratory was the first WHO prequalified laboratory in Central Asia.” 

Today, the Karaganda laboratory is nationally and internationally certified to test drugs which treat diseases including those considered  life-threatening such as TB, HIV/AIDS, and malaria. “Due to our excellent reputation, our laboratory is now being contacted by international pharmaceutical companies to conduct quality assurance testing,” notes Nadezhda. 

The success has increased the government and lab’s commitment to sustain the achieved WHO prequalification status to ensure continued use of lab services to confidently monitor the quality of procured medicines.

Reflecting on the progress the laboratory has made over the past seven years with USAID assistance Nadezhda states, “We work for the people of Kazakhstan and towards strengthening our health systems. Our goal is to provide fellow citizens with first-rate drugs available at local pharmacies. While I am thrilled that we achieved WHO prequalification, it is just the beginning of a long journey ahead. We have a lot more to achieve in the quality assurance of medicines. We will not stop striving to provide international standard quality drugs for our nation and the region.” 

Nadezhda Arhipova with her colleagues outside the Karaganda Lab
Nadezhda Arhipova