ROCKVILLE, Maryland--16 Jul--PRNewswire/ InfoQuest
- USAID-USP Provides Technical Assistance to National Quality Control Laboratories to Strengthen QA/QC Systems Worldwide
The Thailand Ministry of Public Health's Department of Medical Sciences Bureau of Drug and Narcotic (BDN) laboratory has earned World Health Organization (WHO) Prequalification and is now listed in the 25th Edition of the WHO List of Prequalified Quality Control Laboratories. The laboratory has served as Confirmatory Laboratory for quality testing of antimalarial and antituberculosis medicines under the Promoting the Quality of Medicines (PQM) program—a U.S. Agency for International Development (USAID)-funded program that is implemented by the U.S. Pharmacopeial Convention (USP)—as part of this effort. This prequalification will help support global health efforts by improving patient access to priority medicines for malaria, tuberculosis, HIV/AIDS and maternal health.
"We congratulate the BDN laboratory on this significant accomplishment, which will ultimately help to increase the availability of affordable, high-quality medicines for patients," said Dr. Patrick Lukulay, vice president of global health impact programs for USP and director of the PQM program. "BDN has demonstrated that it meets rigorous international standards, and PQM is proud to have collaborated with the laboratory on this important effort."
Under its Prequalification Programme, WHO comprehensively evaluates the quality, safety and efficacy of medicinal products to treat various diseases. Its list of prequalified medicines is a vital tool used to guide United Nations agencies and other groups that are procuring large quantities of essential medicines for developing countries in their purchasing decisions. WHO also prequalifies quality control laboratories that meet recommended international norms and standards for analyzing these medicinal products to help ensure accurate and reliable testing of products.
The Thai BDN laboratory is one of only two WHO Prequalified quality control laboratories in the Mekong region, together with the Vietnam National Institute of Drug Quality Control (NIDQC) in Hanoi, another recipient of PQM technical assistance. The BDN laboratory also achieved ISO/IEC 17025:2005 accreditation in September 2007 and requested an expansion of that accreditation's scope from the accrediting body in November 2012.
"Achieving WHO prequalification is not only an important achievement for our laboratory, but also puts us in a position to contribute to a pressing global health need for facilitating availability of good quality medicines," said Ms. Nidapan Ruangrittinon, director, BDN. "We are very pleased to serve in this role."
Following WHO Prequalification, the Thai BDN laboratory will serve as a resource for expertise, training, and testing to strengthen regional efforts in ensuring medicines quality in Southeast Asia with its participation in newly established initiatives: Build Regional Expertise in Medicines Regulation, Information Sharing, Joint Investigation and Enforcement (BREMERE), an effort of PQM, and Network of Official Control Laboratories (NOMCOL-Asia Pacific), a USP initiative.
The BDN laboratory and PQM program work in a variety of ways to address the medicines quality problems in the Greater Mekong Subregion.BDN actively participates in regional training workshops focused on establishing medicines quality monitoring programs to examine the quality of medicines on the market as well as trainings on compendial analytical methods and procedures for quality control laboratory analysts from Cambodia, Laos and Myanmar. Other collaborations include scientific symposia, reference standards development work, scientific exchange programs and related activities.
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USP — Advancing Health Since 1820
The U.S. Pharmacopeial Convention (USP) is an independent, nonprofit organization that establishes standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements. Its mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. For more information about USP visit http://www.usp.org.
CONTACT: Theresa Laranang-Mutlu
+1-301-816-8167;
[email protected]