USP DQI TRIP REPORT

The team presented at the meeting and met with private sector manufacturers of second-line anti-tuberculosis (TB) medicines, who expressed interest in receiving technical assistance from the PQM program. During the trip, the PQM team conducted follow-up Good Manufacturing Practices (GMP) audits of three state-owned manufacturers of anti-TB medicines in Indonesia: Phapros Indonesia, Indofarma, and Kimia Farma. The team also audited one private sector company, Sandoz Indonesia. Additionally, the team made a supervisory field visit to Medan in Northern Sumatera, one of the Medicine Quality Monitoring (MQM) sites. The PQM team observed the Medan provincial quality control lab staff conducting data collection and basic testing on selected samples during the visit. The team also met with officials from the National Agency of Drug and Food Control, Indonesia, and visited a number of outlets where anti-TB medicines are available, including from both public and private sectors. PQM's Mr. Christopher Raymond was appointed as a member of the national Technical Working Group for Tuberculosis under the Global Fund's Phase II Single Stream of Funding (SSF) project in Indonesia to bring attention to the importance of quality assurance of TB medicines. The team also submitted a draft FY14 work plan to USAID/Indonesia for consideration and feedback. The Promoting the Quality of Medicines (PQM) program is a USAID-funded initiative that aims to improve the quality of medicines in developing countries. PQM provides technical assistance to local manufacturers to improve their good manufacturing practices and product dossier compliance, working towards World Health Organization (WHO) Prequalification. The program also conducts research and surveys to determine medicines quality in the marketplace. Indonesia is considered a high-burden TB country by WHO, with a need to improve the quality assurance system for anti-TB medicines. None of the ATBs produced in Indonesia has achieved WHO Prequalification status for quality or efficacy. With financial support from USAID/Indonesia, PQM has been providing technical assistance on strengthening the post-marketing surveillance capacity of the National Agency of Drug and Food Control, conducting workshops on the WHO PQ Program, and providing technical assistance directly to selected local manufacturers. The PQM team's activities in Indonesia were focused on continuing to provide technical assistance to local manufacturers of first- and second-line ATBs, following up on the implementation of the MQM project for ATBs, supporting the national QC laboratory to implement the MQM project, and providing leadership and expertise at the regional level by participating in the 20th ASEAN PPWG meeting.