USP DQI TRIP REPORT

Agency for International Development (USAID), is the successor of the Drug Quality and Information (DQI) program implemented by the United States Pharmacopeia (USP). PQM is USAID's response to the growing challenge posed by the proliferation of counterfeit and substandard medicines. By providing technical assistance to developing countries, PQM helps 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. 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" (P.E.1.2 -TB). PQM assists countries to implement anti-TB medicine quality monitoring, and in 2008, began providing technical assistance (TA) related to current Good Manufacturing Practices (GMP) 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) Program. Dr. Allan Hong, Manager of Good Manufacturing Practices, traveled to China in April-May 2013 to provide technical assistance to five anti-tuberculosis medicines manufacturers who are in the process of applying for WHO Prequalification (WHO PQ). Dr. Hong performed Good Manufacturing Practices assessments at two companies and followed up with the other three companies to assist them with their WHO PQ submissions. One company expects to receive WHO PQ status in the coming weeks. The trip to China was successful, with Dr. Hong completing GMP assessments for two companies and providing technical assistance for three companies. The assessments were conducted at Reyoung Pharmaceutical Co. Ltd., NCPC Huasheng Pharmaceutical Co. Ltd., HEC Pharmaceutical Co. Ltd., Liaoning Beiqi Pharmaceutical Co. Ltd., and Fuzhou Fuxin Pharmaceutical Co. Ltd. The companies are in various stages of preparing for WHO PQ, with some having completed GMP gap analyses, corrective and preventive actions, and submissions to WHO PQ. Reyoung Pharmaceutical Co. Ltd. is currently producing Streptomycin Finished Pharmaceutical Product (FPP) for export and is interested in producing Capreomycin FPP for WHO PQ. Dr. Hong conducted a GMP gap analysis assessment, with assistance from PQM consultant, Dr. Andre Van Zyl. The inspection report will be issued separately. NCPC Huasheng Pharmaceutical Co. Ltd. completed their corrective and preventive actions (CAPAs) in early 2013, following a WHO PQ inspection in July 2012. The company is expected to receive WHO PQ approval in the coming weeks. HEC Pharmaceutical Co. Ltd. is expected to submit the Levofloxacin Active Pharmaceutical Ingredient (API) Master File (MF) and Finished Pharmaceutical Product (FPP) dossier to WHO PQ by the end of May 2013. Their Moxifloxacin API MF and FPP dossiers are being prepared and should be submitted by the end of June 2013. Liaoning Beiqi Pharmaceutical Co. Ltd. has a good facility and new equipment for the Prothionamide API. Dr. Hong assessed the company for their Prothionamide API WHO PQ project and addressed some technical issues for their Prothionamide APIMF, which was already submitted to WHO PQ. Fuzhou Fuxin Pharmaceutical Co. Ltd. is ready to submit their Kanamycin API Master File to WHO PQ, except for filter validation. PQM is in discussions with third-party technical experts to address this issue.