USP DQI TRIP REPORT

Agency for International Development (USAID), provided technical assistance to the Philippines Food and Drug Administration (FDA) to strengthen medicines quality assurance and quality control (QA/QC) systems. Since 2007, PQM has been actively providing technical assistance to the FDA, the Department of Health (DOH), and the National Tuberculosis Program (NTP) to establish a post-marketing surveillance program, known as the medicines quality monitoring (MQM) program, to monitor the quality of anti-tuberculosis (TB) medicines available on the market and enhance the FDA's regulatory capacity in evaluation and registration of pharmaceutical products. The primary objective of a trip conducted by PQM was to provide training for Philippines FDA officials on process validation from an industry perspective. The training aimed to assist participants in becoming familiar with stringent regulatory agency requirements on pharmaceutical process validation for active pharmaceutical ingredient (API) and for different dosage forms. The training was conducted at the Vivere Hotel in Filinvest Corporate City, Alabang, Muntinlupa City, Philippines, from November 13-16, 2012. The training activities included an opening ceremony, modules on validation background, API process validation, dosage form process validation, and FDA case studies/dossiers, and a closing ceremony. The trainers and facilitators included Dr. Allan Hong, Dr. Bill Wei, Dr. Souly Phanouvong, and Maria Kathrina D. Olivarez. The training evaluation showed that participants were able to understand stringent regulatory agency requirements on pharmaceutical process validation for API and for different dosage forms. In addition to the training, the PQM team attended and presented at the Philippines FDA's "National Consciousness Week against Counterfeit Medicines," met with the Philippines FDA for programmatic updates, met potential second-line anti-tuberculosis medicines manufacturers to follow-up with those who have an interest in the World Health Organization (WHO) Prequalification (PQ) program, met with WHO's Office for the Western Pacific Region (WPRO) to explore collaboration opportunities, and met with several universities to explore the concept of a Bioavailability/Bioequivalence (BA/BE) Center in the Philippines. The training was funded by USAID/Philippines, and the participants included 26 officials from the Philippines FDA. The training was designed to be interactive, and all of the presentation materials were based on industry examples to demonstrate how process validation is practiced by the innovator and generic pharmaceutical industry. At the end of the training, participants were able to understand stringent regulatory agency requirements on pharmaceutical process validation for API and for different dosage forms.