USP DQI TRIP REPORT

The purpose of the assessment was to evaluate the company's compliance with the World Health Organization's current Good Manufacturing Practices (WHO cGMPs) main principles for pharmaceutical products. Akrikhin Pharmaceuticals Co. is interested in obtaining WHO Prequalification for Prothionamide 250mg tablets. The assessment covered six key systems: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System. The objective of the assessment was to provide comprehensive GMP coverage to the facility and products in a short period of time and to determine whether the manufacturer has the systems in place to operate in a state of control and in compliance with WHO cGMPs. The assessment revealed that Akrikhin Pharmaceuticals Co. had no critical observations and that they have the capability and necessary systems in place to maintain control and operate in compliance with WHO cGMPs. The company's manufacturing facility, warehouse facility, and laboratory facility were evaluated, and key findings included the need to fully validate the manufacturing resource planning system and to enhance temperature monitoring of active pharmaceutical ingredient (API) storage and reference standards storage. PQM presented the findings of the visit on the final day to key Akrikhin personnel, and a complete confidential report of the visit observations, findings, and recommendations will be sent to the company separately. Based on the areas inspected, Akrikhin Pharmaceuticals has all of the required systems to successfully participate in the WHO PQ Programme for Prothionamide tablets. The next steps for Akrikhin Pharmaceuticals include initiating a new bioavailability/bioequivalence (BA/BE) study at a WHO-approved facility, initiating long-term stability testing at 30+/- 2°C, 75+/- 5% RH, contacting the API supplier for an updated drug master file (DMF), and beginning the compilation of the dossier. The assessment was funded by USAID core funding for Tuberculosis, and the PQM program is USAID's response to the growing challenge posed by the proliferation of counterfeit and substandard medicines. Tuberculosis (TB) is a global concern, and PQM has actively contributed to the USAID strategic objective of "increased use of effective interventions to reduce the threat of infectious diseases, including tuberculosis." PQM assists countries to implement anti-TB medicine quality monitoring, and in 2008, began providing technical assistance to interested companies on the preparation of medicine dossiers they submit to the World Health Organization (WHO) with their "Expressions of Interest" for the WHO Prequalification (PQ) Programme. The PQM program is the successor of the Drug Quality and Information (DQI) program implemented by the United States Pharmacopeia (USP), and it provides technical assistance to developing countries to build local capacity in medicine quality assurance systems, increase the supply of quality medicines to priority USAID health programs, and ensure the quality and safety of medicines globally.