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Angie Drakulich was editorial director of Pharmaceutical Technology.
The Laboratory Services Division of the Philippine Food and Drug Administration (FDA) has attained internationally recognized accreditation for its testing and calibration laboratories, according to a July 12, US Pharmacopeia (USP) announcement.
The Laboratory Services Division of the Philippine Food and Drug Administration (FDA) has attained internationally recognized accreditation for its testing and calibration laboratories, according to a July 12, 2010, US Pharmacopeia (USP) announcement. The specific accreditation, the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2005, serves as the industry’s top standard for being able to provide quality and valid medicines to consumers.
USP, along with the US Agency for International Development (USAID), has been working with the Philippine regulatory body to achieve accreditation since 2006 through its Promoting the Quality of Medicines Program (PQM). PQM is a five–year, $35-million collaboration focused on assuring the quality, safety, and efficacy of medicines essential to USAID's priority health programs.
USP sent staff to train laboratory professionals at the Philippines FDA on good laboratory practices, dissolution testing, and high-performance liquid chromatography for a fixed-dose combination anti-tuberculosis (TB) drug. A primary goal of the Philippines training was to equip local FDA analysts with the appropriate skills to determine the quality of anti-TB medicines in the country. Substandard and counterfeit TB medicines-along with drugs for other common diseases in developing countries-are a growing risk to countries such as the Philippines. "Such medicines have the potential to undermine decades of investments in public health,” said Alonzo L. Fulgham, acting administrator of USAID, in a USP press release about the partnership. “Without good quality, safe medicines to treat diseases such as HIV/AIDS, malaria and tuberculosis, the impact of other health initiatives may be weakened. The PQM Program focuses on this critical aspect of combating these diseases."
Added Philippine FDA Director Nancy Tacandong in the USP press release, “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.”
The USP program, with funding from USAID and the Philippines Mission, also helped the Philippines’ FDA establish a quality-monitoring program for anti-TB medicines. To continue the relationship, USP plans to host visiting scientists from the country later in 2010.
USP is also carrying out a Drug Quality and Information program to provide technical assistance in drug quality assurance, to develop and disseminateunbiased drug and therapeutic information, to train healthcare workers to better use medicines, and to provide scientific evidence for healthcare decision making indeveloping countries. The program, with support from USAID, is underway inNepal, Russia, Mozambique, Senegal, Vietnam, Cambodia, Thailand, Laos,China, Kazakhstan, and Romania.
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