Medicine quality in Philippines and region strengthened with Philippine FDA's accreditation

July 12, 2010

Rockville, Md., July 12, 2010 -- In an effort that will contribute to raising the quality of medicines in the Philippines and surrounding regions, the Laboratory Services Division (LSD) of the Philippine Food and Drug Administration (FDA) has attained the internationally recognized accreditation for testing and calibration laboratories, International Organization for Standardization/ International Electrotechnical Commission (ISO/IEC) 17025:2005. The FDA celebrates this achievement with its partners who assisted the laboratory in earning accreditation, including the U.S. Agency for International Development (USAID) and the Promoting the Quality of Medicines (PQM) Program, implemented by the U.S. Pharmacopeial Convention (USP).

"This is a milestone not only for the FDA, but for the people of the Philippines and the surrounding region," said Ms. Maria Lourdes C. Santiago, M.Sc. M.M., chief, LSD. We are demonstrating our commitment to public health by adherence to international standards for laboratory quality management. We greatly appreciate the timely support from USAID and PQM, which allowed us to anticipate and address issues prior to the formal accreditation process."

Added Ms. Nancy Tacandong, director, FDA, "I am thankful that USAID and PQM came at an opportune time and helped FDA in gaining accreditation. Filipino consumers and export industries stand to benefit from this achievement of the FDA."

PQM staff conducted training at the Philippines FDA on Good Laboratory Practices (GLP), Dissolution testing, and High Performance Liquid Chromatography (HPLC) analysis focused on the fixed-dose combination anti-tuberculosis (TB) medicine containing pyrazinamide, rifampicin, isoniazid and ethambutol. One of the main goals of this training was to equip analysts at both the main FDA site and the satellite laboratories in Cebu and Davao with the necessary analytical skills to determine the quality of anti-TB medicines in the Philippines.

The Philippine Accrediting Organization (PAO) awarded the FDA ISO/IEC accreditation for a wide scope of chemical and microbiological testing. This accreditation, recognized as the industry's top standard, validates that the FDA can provide valid and trustworthy data to the Department of Health, helping to ensure the quality of medicines to the country's citizens.

The PQM Program has provided technical assistance to the FDA since 2006 and established a medicines quality monitoring program for anti-TB medicines in the Philippines through funding from the USAID/Philippines Mission. According to Dr. Patrick Lukulay, director of the PQM Program, "I'm gratified that the LSD has earned accreditation from an international standards body. Through the PQM Program, USAID and USP are dedicated to helping national laboratories in developing countries improve public health through a science-based focus on medicines quality. To further this, USP headquarters will host visiting scientists from the LSD later this year to provide training on advanced quality lab techniques."

USAID is an independent agency that provides economic, development and humanitarian assistance around the world in support of the foreign policy goals of the United States. The PQM Program, implemented by USP, is a cooperative agreement with USAID that works to improve medicine quality in developing countries. The program focuses on the availability of high-quality medicines to treat life-threatening diseases including HIV/AIDS, malaria and tuberculosis. Lack of access to quality-assured medicines is a major public health threat throughout much of the world.
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The American people, through the U.S. Agency for International Development, have provided economic and humanitarian assistance worldwide for nearly 50 years.

USP--Advancing Public Health Since 1820

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP's standards are recognized and used worldwide. For more information about USP visit http://www.usp.org.

US Pharmacopeia

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